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Business

FDA Authorizes First At-Home COVID-19 Self Test

The U.S. Food and Drug Administration has authorized the first COVID-19 diagnostic at-home self test that provides results in 30 minutes or less.

The Lucira COVID-19 All-In-One Test Kit by Lucira Health, Inc., a single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, has received FDA’s emergency use authorization or EUA.

The Lucira test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. The test until now was authorized for prescription use only.

The test can also be used in point-of-care or POC settings, e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms, for all ages. However, to test individuals younger than 14 years old, a healthcare provider must collect the samples.

The Lucira test, which works by swirling the self-collected sample swab in a vial that is then placed in the test unit, provides results in 30 minutes or less.

The test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19.

One can read the results directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. The FDA urged individuals with positive results to self-isolate and seek additional care from their health care provider.

The prescribing health care providers are required to report all results from the Lucira test to their relevant public health authorities in accordance with local, state and federal requirements.

Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting.

FDA Commissioner Stephen Hahn said, “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

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Business

Moderna Says COVID-19 Vaccine Candidate More Than 94% Effective

Moderna, Inc. (MRNA) said Monday that preliminary data from the Phase 3 study of its coronavirus vaccine candidate, mRNA-1273, has shown the vaccine to be more than 94 percent effective. Following the news, the company’s stock jumped more than 15 percent in pre-market to trade at $103.

The company said that it was informed by the NIH-appointed Data Safety Monitoring Board or DSMB for the Phase 3 study of mRNA-1273 that the trial met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 percent.

The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases or NIAID, and the Biomedical Advanced Research and Development Authority or BARDA.

The first interim analysis evaluated 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group. This resulted in an estimated vaccine efficacy of 94.5 percent.

Based on these interim safety and efficacy data, Moderna said it plans to submit for an Emergency Use Authorization or EUA with the U.S. Food and Drug Administration in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data, with a median duration of at least two months.

Moderna also plans to submit applications for authorizations to global regulatory agencies.

By the end of 2020, Moderna expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The company said it remains on track to manufacture 500 million to 1 billion doses of the vaccine globally in 2021.

Last Monday, Pfizer Inc. (PFE) and German biotech firm BioNTech SE (BNTX) said that their mRNA-based coronavirus vaccine candidate, BNT162b2, was found to be more than 90 percent effective in preventing COVID-19 among patients without prior evidence of infection.

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Business

Pre-market Movers In Healthcare Sector: DRAD, SUPN, ARGX, AZN, APVO…

What’s moving these stocks in the pre-market hours today?

In the Green

1. Digirad Corporation (DRAD) is up over 25% at $3.20 in pre-market trading Wednesday, following news that it has entered into a Stock Purchase Agreement to sell its DMS Health Technologies Inc. business unit for $18.75 million. The deal is expected to close in January 2021.

2. Supernus Pharmaceuticals, Inc. (SUPN) is up more than 20% at $21.94 in pre-market hours today, following its third quarter financial results and upwardly revised revenue outlook for the year. The FDA decision on the company’s drug candidate SPN-812, proposed for the treatment of children and adolescents with attention deficit hyperactivity disorder, is slated for November 8.

3. argenx SE (ARGX) is up more than 6% at $273.81 in pre-market hours today on no news. The company is on track to file its Biologics License Application for Efgartigimod in generalized myasthenia gravis to the FDA by end of 2020.

4. AstraZeneca PLC (AZN) is up over 3% at $53.59 in pre-market hours today. The company is slated to report third-quarter financial results tomorrow (Nov.5).

5. ObsEva SA (OBSV) is up more than 3% at $1.99 in pre-market hours on no news. The company is scheduled to host a live symposium and present oral communication at SEUD Online Week 2020 tomorrow (Nov.5). The company will present the positive results from PRIMROSE 2, a phase III clinical trial comparing its investigational drug Yselty (Linzagolix) at different dose regimens versus placebo in the treatment of heavy menstrual bleeding due to uterine fibroids tomorrow. ObsEva is planning to make regulatory submissions for Yselty to the European Medicines Agency in the fourth quarter and to the FDA in the first half of 2021.

6. Evoke Pharma Inc. (EVOK) is up over 2% at $3.55 in pre-market trading today on no news. The company commercially launched Gimoti nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis as recently as late last month. Gimoti secured FDA approval in June of this year.

In the Red

1. Aptevo Therapeutics Inc. (APVO) is down over 8% at $10.27 in pre-market trading today, giving back some of what it gained yesterday. The stock was up more than 78% yesterday after the company reported that complete remission has been observed in a patient in a Phase 1/1b trial of APVO436 in acute myeloid leukemia (AML) and myelodysplastic syndrome patients.

2. Acorda Therapeutics Inc. (ACOR) is down over 9% at $0.98 in pre-market trading Wednesday. The company disclosed its financial results for the third quarter ended September 30, 2020 after the bell yesterday. The total net revenue in Q3, 2020, increased to $53 million from $47.7 million in the year-ago same quarter. However, the product revenue, which comprises of Inbrija and Ampyra, were $34.6 million in Q3, 2020, down from $44.8 million in Q3, 2019.

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Business

ANAB, GSK Amend Agreement, BSGM Plunges As COVID-19 Trial Flops, CATB Craters, MRTX Abuzz

Today’s Daily Dose brings you news about the amended immuno-oncology collaboration agreement between AnaptysBio and GlaxoSmithKline, BioSig discontinuing its phase II trial of investigational antiviral Merimepodib in COVID-19, the failure of Catabasis’ phase III trial of Edasalonexent in Duchenne muscular dystrophy, and Mirati’s promising early data of Adagrasib in lung cancer.

Read on…

1. All ends well for AnaptysBio, GlaxoSmithKline

AnaptysBio Inc. (ANAB) and GlaxoSmithKline (GSK) have amended their immuno-oncology collaboration agreement.

The immuno-oncology collaboration agreement was originally signed between AnaptysBio and Tesaro in 2014.

When GlaxoSmithKline acquired Tesaro in 2018, it inherited the collaboration agreement, approved ovarian cancer drug Zejula, and investigational drug Dostarlimab, which was developed as part of a collaboration between Tesaro and AnaptysBio.

Under the terms of the amended agreement, GlaxoSmithKline has agreed to increase the Dostarlimab royalties to AnaptysBio from 4-8% to 8-25% of global net sales.

Dostarlimab is under FDA review for its first indication endometrial cancer, with a decision expected this quarter. If the global net sales of Dostarlimab are below $1 billion, AnaptysBio will receive 8% royalty and if the global net sales are above $1 billion, AnaptysBio will receive royalty in the range of 12-25%.

GlaxoSmithKline has also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all global net sales of Zejula. In addition, GlaxoSmithKline has agreed to pay AnaptysBio a one-time cash payment of $60 million within 30 days.

In August of this year, AnaptysBio had expressed its displeasure over GlaxoSmithKline’s plan to begin a phase III clinical trial of Zejula, involving a third-party anti-PD-1 antibody, i.e., Merck’s Keytruda, in non-small cell lung cancer without AnaptysBio’s consent.

AnaptysBio had notified GlaxoSmithKline that it is in breach of its obligations under the 2014 immuno-oncology collaboration agreement. A suit was also filed by AnaptysBio in Delaware Chancery Court seeking GlaxoSmithKline to return all PD-1 antagonist related rights under the 2014 agreement, including the Dostarlimab program, across all clinical indications.

Now that the collaboration agreement has been amended, AnaptysBio has provided GlaxoSmithKline with freedom to conduct development and commercialization of Zejula in combination with any third-party molecules.

ANAB closed Monday’s trading at $27.73, up 7.77%.

2. BioSig Discontinues phase II Trial of Merimepodib in COVID-19

Shares of BioSig Technologies Inc. (BSGM) plunged more than 39% on Monday, following disappointing news related to its investigational antiviral Merimepodib.

The company’s majority owned subsidiary, ViralClear Pharmaceuticals, Inc. has decided to discontinue its phase II study of oral Merimepodib in combination with Gilead’s intravenous Remdesivir in adult patients with advanced COVID-19 as the trial was unlikely to meet its primary safety endpoints.

The company noted that it does not intend to further develop Merimepodib but will see if other parties are interested in acquiring or licensing Merimepodib.

BSGM closed Monday’s trading at $3.03, down 39.64%.

3. Catabasis Throws in the Towel on DMD drug Candidate Edasalonexent

Catabasis Pharmaceuticals Inc.’s (CATB) phase III trial of Edasalonexent in Duchenne muscular dystrophy, dubbed PolarisDMD, has not met the primary and secondary endpoints.

The primary endpoint was a change from baseline in the North Star Ambulatory Assessment (NSAA) over one year of Edasalonexent compared to placebo. The secondary endpoint was the timed function tests such as time to stand, 10-meter walk/run and 4-stair climb.

In view of the disappointing results, Catabasis is stopping activities related to the development of Edasalonexent, including the ongoing GalaxyDMD open-label extension trial.

The company plans to work with external advisors to explore and evaluate strategic options going forward.

CATB closed Monday’s trading at $5.36, down 7.90%. In after-hours, the stock was down over 62% at $2.00

4. Mirati Therapeutics Hits New High on promising early data of Adagrasib

Shares of Mirati Therapeutics Inc. (MRTX) briefly crossed the $200 mark in intraday trading Monday, following promising data from the company’s phase I/Ib and phase II monotherapy cohorts of Adagrasib in patients with advanced Non-Small Cell Lung Cancer.

According to the company, Adagrasib demonstrated a 45% confirmed *objective response rate and 96% disease control rate across the phase 1/1b and phase II monotherapy cohorts. (Objective response rate is the percentage of patients whose disease decreased following treatment. Disease control rate is the percentage of patients whose disease shrinks or remains stable over a certain time period). (Source: Evidence based Medicine and Practice Journal).

Enrollment is complete in the phase II cohort of Adagrasib as a monotherapy treatment for patients in 2nd/3rd line NSCLC, and a New Drug Application seeking accelerated approval for Adagrasib is expected to be submitted in the second half of 2021.

The company also reported initial preclinical data for MRTX1133, which demonstrated significant tumor regression in mutant animal models. The company plans to make IND filing for advancing the compound into clinical trials in the first half of next year.

Adagrasib is a selective KRAS G12C inhibitor while MRTX1133 is a selective KRAS G12D inhibitor. The KRAS G12D mutation drives tumor growth and poor outcomes in an even greater number of cancer patients than the KRAS G12C mutation, noted the company.

In other news, the company announced that it intends to sell in an underwritten public offering $700.0 million of shares of its common stock and that a selling stockholder intends to offer 375,000 shares in the offering. Mirati will not receive any proceeds from the sale of shares in the offering by the selling stockholder.

MRTX touched an all-time high of $211.50 in intraday trading Monday, before closing at $196.68, up 9.15%.

5. Stocks That Hit New Highs/Lows

Shattuck Labs Inc. (STTK) closed at a new high of $23.78, up 9.28%.

Spruce Biosciences Inc. (SPRB) closed at a new high of $19.25, up 6.06%.

Amicus Therapeutics Inc. (FOLD) closed at a new high of $18.75, up 1.46%.

EyePoint Pharmaceuticals Inc. (EYPT) closed at a new low of $0.41, down 10.47%.

Baudax Bio Inc. (BXRX) closed at a new low of $1.29, down 11.64%.

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Economy

Pre-market Movers In Healthcare Sector: MGEN, EQ, SNSS, IPHA, BLCM, AXGT…

What’s moving these stocks in the pre-market hours today?

In the Green

1. Miragen Therapeutics Inc. (MGEN) is up over 34% at $1.88 in pre-market hours Friday on no news. On Oct.28, the company acquired Viridian Therapeutics, Inc., a privately held biotechnology company, sending the stock up more than 140%. The acquisition adds clinical stage anti-IGF-1R monoclonal antibody, VRDN-001, intended for the treatment of thyroid eye disease, to Miragen’s pipeline.

2. Equillium Inc. (EQ) is up over 24% at $7.47 in pre-market hours today, adding to yesterday’s gain of 10%. The company has received FDA clearance to initiate a phase III clinical trial of Itolizumab in hospitalized COVID-19 patients suffering from acute respiratory distress syndrome, dubbed EQUINOX. Enrollment in the trial is expected to begin this quarter, with initial clinical data expected mid-year 2021.

3. Genetic Technologies Limited (GENE) is up over 5% at $3.22 in pre-market hours, following an update of its business.

4. Sunesis Pharmaceuticals Inc. (SNSS) is up more than 4% at $1.22 in pre-market hours Friday on no news. The company is focused on developing SNS-510, a PDK1 inhibitor. SNS-510 is in IND-enabling studies. A 1-for-10 reverse stock split was implemented on September 3, 2020.

5. Innate Pharma S.A. (IPHA) is up over 4% at $4.10 in pre-market hours Friday. The company’s lead compound is Monalizumab, which is partnered with AstraZeneca (AZN). A phase III clinical trial of Monalizumab in combination with Eli Lilly’s Erbitux in patients with immuno-oncology (IO)-pre-treated recurrent or metastatic squamous cell carcinoma of the head and neck, dubbed INTERLINK-1, is underway.

6. BioNTech SE (BNTX) is up over 3% at $87.60 in pre-market hours today, adding to yesterday’s gain of 9%. The company, along with Pfizer (PFE) is developing BNT162b2, a vaccine candidate against COVID-19. This vaccine candidate is currently being evaluated in a global phase III study that is underway at more than 150 clinical sites.

In the Red

1. Bellicum Pharmaceuticals Inc. (BLCM) is down over 36% at $3.75 in pre-market trading Friday, on disappointing interim data from a phase I dose-escalation trial of BPX-601 in patients with relapsed/refractory metastatic pancreatic cancer. The company has priced an underwritten offering of $25 million priced at-the-market and has also announced a reduction in its workforce by 79%.

2. Axovant Gene Therapies Ltd. (AXGT) is down over 34% at $2.40 in pre-market hours today on news of a likely delay in its planned randomized, sham-controlled study of AXO-Lenti-PD gene therapy for the treatment of Parkinson’s disease, dubbed EXPLORE-PD. Earlier it was expected that dosing in the EXPLORE-PD study would begin in 2021. But now, the company has said that the trial is unlikely to enroll patients by the end of 2021.

3. Cellect Biotechnology Ltd. (APOP) is down over 10% at $1.87 in pre-market hours today, giving back some of what it gained yesterday. The stock was up over 22% yesterday on news of the company entering into and commencing a collaborative development program with Sweden-based XNK Therapeutics, a pioneer in natural killer (NK) cell-based therapies.

4. Aptorum Group Limited (APM) is down more than 7% at $2.10 in pre-market hours today. Last month, the company launched Aptorum Innovations – an infectious disease liquid biopsy diagnostics subsidiary and its newly established exclusive in-licensing arrangements with Accelerate Technologies Pte Ltd – to co-develop novel molecular-based rapid pathogen identification and detection diagnostics (“RPIDD”) technology.

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Business

LLY Pauses COVID-19 Antibody Trial, JNJ Boosts Annual Outlook, Double Whammy For GOSS

Today’s Daily Dose brings you news about Lilly temporarily halting phase III trial of COVID-19 antibody, Gossamer Bio’s oral GB001 flunking in both asthma and chronic rhinosinusitis trials, encouraging data from Regeneron/Sanofi’s Dupixent trial, and Johnson & Johnson’s rosy outlook.

Read on…

1. Lilly Pauses Phase III trial of COVID-19 Antibody

A phase III trial evaluating Eli Lilly and Co.’s (LLY) investigational monoclonal antibody LY-CoV555 in combination with standard of care Gilead SciencesInc.’s (GILD) Remdesivir in hospitalized COVID-19 patients has been paused due to a potential safety concern, according to reports.

Launched in August, the phase III study, dubbed ACTIV-3, was initially designed to enroll about 300 volunteers who have been hospitalized with mild to moderate COVID-19 and is led by the National Institutes of Health.

Another NIH-led phase III study of LY-CoV555, dubbed ACTIV-2, is ongoing in patients with mild to moderate symptoms of COVID-19 who have not been hospitalized.

Last week, Lilly had submitted an initial request for emergency use authorization for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19 based on data from an interim analysis of another trial, dubbed BLAZE-1, which is a phase II study.

It is not known whether the pausing of the ACTIV-3 study will impact the other ongoing LY-CoV555 trials.

On Monday, Johnson & Johnson (JNJ) announced that it is temporarily suspending a phase III study of its COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant.

In September, AstraZeneca plc’s (AZN) phase III trial of COVID-19 vaccine candidate, AZD1222, which was underway in the U.S., UK, Brazil, South Africa, and other countries, was put on hold over a safety issue. While the phase III trial has resumed in other countries now, it continues to remain on hold in the U.S.

LLY closed Tuesday’s trading at $150.08, down 2.85%.

2. Double Whammy for Gossamer as GB001 Fails In Two Trials

Shares of Gossamer Bio Inc. (GOSS) plunged more than 25% on Tuesday, following disappointing data from its phase II trials of oral GB001 in asthma and chronic rhinosinusitis.

In a phase IIb trial of oral GB001 in patients with moderate-to-severe eosinophilic asthma, dubbed LEDA, the primary endpoint of asthma worsening was not met. However, statistically significant improvements in the secondary endpoint of time to first asthma worsening compared to placebo were observed.

The company noted that it will discuss its findings related to oral GB001 in asthma with global regulatory authorities and continue discussions with potential strategic partners.

In a phase IIa trial of oral GB001 in patients with chronic rhinosinusitis with and without nasal polyps, dubbed TITAN, the primary endpoint of change from baseline in *SNOT-22 score at Week 16, and the secondary endpoint of change from baseline to Week 16 in nasal polyp score were not met. (*SNOT-22 or Sino-Nasal Outcome Test is a validated questionnaire that assesses patients with chronic rhinosinusitis).

The company has decided not to pursue the development of GB001 in chronic rhinosinusitis.

GOSS closed Tuesday’s trading at $10.09, down 25.75%.

3. JNJ Boosts Annual Outlook

Johnson & Johnson (JNJ), which reported better-than-expected third-quarter financial results on Tuesday, has boosted its outlook for full-year 2020.

On an adjusted basis, net earnings for the third quarter of 2020 rose to $5.87 billion or $2.20 per share from $5.67 billion or $2.12 per share in the year-ago quarter. On average, Wall Street analysts expected earnings of $1.98 per share.

Sales for the recent third quarter were $21.08 billion compared to $20.73 billion in the same quarter last year and well above analysts’ consensus estimate of $20.20 billion.

Looking ahead, the company now expects operational sales to range between $82.0 billion and $82.8 billion, up from its prior forecast range of $81.0 billion and $82.5 billion. The consensus estimate for sales predicted by Wall Street analysts for the year is $81.03 billion.

JNJ closed Tuesday’s trading at $148.36, down 2.29%.

4. Regeneron/Sanofi’s Cash Cow Dupixent Does It Again!

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi’s (SNY) pivotal phase III trial of Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma has met its primary and all key secondary endpoints.

Despite standard-of-care therapy such as inhaled corticosteroids, children with uncontrolled moderate-to-severe asthma are said to be at risk of severe asthma attacks and this often leads to frequent hospitalizations and emergency room visits.

In the phase III trial, dubbed LIBERTY ASTHMA VOYAGE, Dupixent significantly reduced severe asthma attacks by up to 65% over one year compared to placebo. In addition, the drug was associated with a significant and rapid improvement in lung function within two weeks and it was sustained for up to 52 weeks.

Commenting on the trial results, John Reed, Global Head of Research and Development at Sanofi, said, “Dupixent is the only biologic shown in a controlled Phase 3 trial to improve lung function in children, which is generally consistent with results seen in the adolescent and adult trials”.

The companies are planning to make U.S. and EU regulatory submissions, seeking approval for Dupixent for children aged 6-11 years with uncontrolled moderate-to-severe asthma, by the first quarter of 2021.

Dupixent is already approved for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis, as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older and as an add-on maintenance treatment in adult patients with chronic rhinosinusitis with nasal polyposis.

The drug recorded annual sales of $2.32 billion in 2019. SVB Leerink analyst Geoffrey Porges expects Dupixent to bring in sales of $3.86 billion in 2020.

REGN closed Tuesday’s trading at $607.98, up 1.07%.

5. Stocks That Moved On No News

Aethlon Medical Inc. (AEMD) closed Tuesday’s trading at $1.97, up 33.11%.

SOS Limited (SOS) closed Tuesday’s trading at $2.69, up 27.49%.

BiondVax Pharmaceuticals Ltd. (BVXV) closed Tuesday’s trading at $40.79, up 19.90%.

Liquidia Technologies, Inc. (LQDA) closed Tuesday’s trading at $4.08, down 29.53%.

Avenue Therapeutics Inc. (ATXI) closed Tuesday’s trading at $3.87, down 14.57%.

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Business

FDA Approves Regeneron’s Inmazeb To Treat Ebola

The U.S. Food and Drug Administration has approved Inmazeb, an antibody cocktail made by Regeneron Pharmaceuticals Inc. (REGN), for the treatment of infection caused by Zaire ebolavirus (Ebola virus) in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

Inmazeb or REGN-EB3 is a mixture of atoltivimab, maftivimab, and odesivimab-ebgn monoclonal antibodies.

In a large clinical trial, Inmazeb showed superiority compared to other investigational agents (ZMapp and remdesivir) with respect to mortality. The treatment was most effective when given early in the course of disease, Regeneron said in a statement on Wednesday.

Inmazeb was evaluated in 382 adult and pediatric patients with confirmed Zaire ebolavirus infection in PALM clinical trial, and as part of an expanded access program conducted in the Democratic Republic of the Congo (DRC) during an Ebola virus outbreak in 2018-2019.

In the PALM trial, the safety and efficacy of Inmazeb was evaluated in a multi-center, open-label, randomized controlled trial, in which 154 patients received Inmazeb (50 mg of each monoclonal antibody) intravenously as a single infusion, and 168 patients received an investigational control.

Of the 154 patients who received Inmazeb, 33.8% died after 28 days, compared to 51% of the 153 patients who received a control drug.

The FDA advised that patients who receive Inmazeb should avoid getting a live Ebola vaccine at the same time, because the drug may reduce the vaccine’s efficacy.

The FDA approved Ervebo, the first vaccine for the prevention of Ebola virus disease, in December 2019.

In March 2014, the World Health Organization (WHO) reported a major Ebola outbreak in Guinea, a western African nation. The disease then rapidly spread to the neighboring countries of Liberia and Sierra Leone.

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Business

ATXI Plunges On Thumbs-down, VYGR’s Huntington’s Disease Trial On Hold, Deal Or No Deal For SURF?

Today’s Daily Dose brings you news about FDA declining approval for Avenue Therapeutics/Fortress Biotech’s pain drug IV Tramadol, encouraging data from Gilead/ Galapagos’ Ulcerative Colitis trial, reports of Surface Oncology receiving a takeover offer from GlaxoSmithKline, and clinical hold slapped by the FDA on Voyager’s Investigational New Drug application for VY-HTT01 for the treatment of Huntington’s disease.

Read on…

1. Avenue Therapeutics Reels from FDA Rejection

Shares of Avenue Therapeutics Inc. (ATXI) plunged to a 52-week low of $4.46 on Monday, following a disappointing regulatory update related to its investigational intravenous (“IV”) Tramadol.

The FDA has refused approval to IV Tramadol, proposed for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.

In its Complete Response Letter, the FDA has stated that IV Tramadol is not safe for the intended patient population. Specifically, if a patient requires an analgesic between the first dose of IV Tramadol and the onset of analgesia, a rescue analgesic would be needed. The likely choice would be another opioid, which would result in opioid “stacking” and increase the likelihood of opioid-related adverse effects. The regulatory agency has also sought an adequate terminal sterilization validation before IV Tramadol could be approved, which is planned for later this quarter.

Avenue Therapeutics is a majority-controlled subsidiary company of Fortress Biotech (FBIO).

ATXI closed Monday’s trading at $4.53, down 58.97%.

2. Gilead/Galapagos’ SELECTION Trial in Ulcerative Colitis Yields Encouraging Data

Gilead Sciences Inc. (GILD) and Galapagos NV’s (GLPG) phase 2b/3 trial of Filgotinib in adult patients with moderately to severely active ulcerative colitis has yielded encouraging results.

According to the trial results, compared to placebo, a significantly higher proportion of patients treated with Filgotinib 200 mg achieved clinical remission at Week 10 and maintained *remission through Week 58. In addition, significantly more patients achieved six-month corticosteroid-free remission.

Ulcerative colitis is characterized by inflammation of the mucosal lining of the colon and rectum. Despite current treatments, many patients experience fecal urgency, incontinence, recurring bloody diarrhea, and the need to empty their bowels frequently, often accompanied by abdominal pain, poor sleep, and fatigue. (*Remission refers to either the reduction or disappearance of the signs and symptoms of a disease).

The study, dubbed SELECTION, involved 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis.

Filgotinib (200 mg and 100 mg tablets) is approved in Europe and Japan for the treatment of adults with moderately to severely active rheumatoid arthritis but is not approved anywhere for the treatment of ulcerative colitis.

The FDA declined to approve Filgotinib for moderately to severely active rheumatoid arthritis in August of this year, expressing concerns regarding the overall benefit/risk profile of the drug.

GLPG closed Monday’s trading at $148.25, up 1.13%.

3. Surface Oncology – Deal or No Deal?

Shares of Surface Oncology Inc. (SURF) closed at a two-year high of $9.39 on Monday, following reports that it has received a takeover offer from GlaxoSmithKline plc (GSK).

Surface Oncology is a clinical-stage immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. The company’s pipeline includes two wholly-owned lead programs – SRF617, which is under a phase 1/1b study in patients with solid tumors, and SRF388, which is under a phase I trial in patients with advanced solid tumors. Surface Oncology has a collaboration with Merck (MRK) to evaluate the safety and efficacy of combining SRF617 with Merck’s blockbuster drug KEYTRUDA.

Another clinical program of the company is a phase I trial evaluating NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers.

Novartis has a worldwide exclusive license to develop and commercialize NZV930 as part of its broad strategic collaboration with Surface.

SURF closed Monday’s trading at $9.39, up 32.07%.

4. FDA Slaps Clinical Hold on Voyager’s IND for Huntington’s disease Trial

Voyager Therapeutics Inc.’s (VYGR) Investigational New Drug application for VY-HTT01 for the treatment of Huntington’s disease has been placed on clinical hold by the FDA.

Huntington’s disease, caused by mutations in the HTT gene, is a fatal genetic disease affecting approximately 40,000 people in the U.S. that results in the progressive decline of motor and cognitive functions. There are currently no approved treatments targeting the underlying cause of the disease.

Voyager’s investigational VY-HTT01 is a one-time AAV-based gene therapy treatment designed to knockdown expression of the HTT gene, and potentially slow the progression of both motor and cognitive symptoms.

Last month, the company submitted the Investigational New Drug application to begin the first-in-human clinical trial of VY-HTT01 in Huntington’s disease patients. The application has been placed on hold pending the resolution of certain chemistry, manufacturing, and controls (CMC) matters.

VYGR closed Monday’s trading at $12.02, up 3.80%. In after-hours, the stock fell 11.06% to $10.69.

5. Stocks That Moved On No News

Shineco Inc. (TYHT) closed Monday’s trading at $3.23, up 14.13%.

Five Prime Therapeutics Inc. (FPRX) closed Monday’s trading at $6.09, up 13.20%.

Organovo Holdings Inc. (ONVO) closed Monday’s trading at $10.11, up 11.71%.

AgeX Therapeutics Inc. (AGE) closed Monday’s trading at $2.02, down 21.09%.

ProPhase Labs Inc. (PRPH) closed Monday’s trading at $4.76, down 19.05%.

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Business

Healthcare IPOs For October 9

We are just days into the final quarter of the year. The number of healthcare firms that have gone public on the U.S. stock exchanges so far this month is 4.

Let’s take a look at the IPOs scheduled for Friday (Oct 9).

1. Kronos Bio Inc.

San Mateo, California-based Kronos Bio is a clinical-stage biopharmaceutical company developing novel cancer therapeutics.

Founded in 2017, the company plans to list its stock on the Nasdaq Global Select Market under the symbol “KRON” on October 9, 2020.

About 10.29 million shares of the company’s common stock will be sold in the offering, with the price expected to be between $16.00 and $18.00 per share. The underwriters have an option for 30 days to purchase up to 1.54 million additional shares.

Underwriters of the IPO:

Goldman Sachs & Co. LLC, Jefferies LLC, Cowen and Company, LLC Piper Sandler & Co.

Pipeline & Near-term Catalysts:

— The company’s lead candidate, Entospletinib (ENTO), acquired from Gilead Sciences, is an orally available inhibitor of spleen tyrosine kinase (Syk) for the treatment of acute myeloid leukemia (AML).

A registrational phase II/III clinical trial of Entospletinib in newly-diagnosed AML patients with NPM1 mutations is expected to be initiated in 2021, with data readout anticipated in 2023.

A phase I/II clinical trial of Entospletinib in patients with relapsed or refractory FLT3 mutated AML is also expected to be initiated in 2021, with topline data anticipated in 2022.

The second product candidate, KB-0742, is an orally bioavailable inhibitor of cyclin dependent kinase 9 (CDK9), for the treatment of MYC-amplified solid tumors.

An Investigational New Drug application, seeking clearance to advance KB-0742 into clinical trial is expected to be submitted to the FDA in the fourth quarter of 2020.

Initiation of a phase I/II clinical trial of KB-0742 in patients with advanced solid tumors is expected in 2021.

2. Shattuck Labs Inc.

Austin, Texas-based Shattuck Labs, Inc. is scheduled to go public on the Nasdaq Global Select Market under the symbol “STTK” on October 9, 2020.

Founded in 2016, Shattuck Labs is a clinical-stage biotechnology company developing dual-sided fusion proteins through its proprietary Agonist Redirected Checkpoint (ARC) platform for the treatment of cancer and autoimmune diseases.

The company has offered to sell 10.0 million shares of common stock in the offering, and the underwriters have a 30-day option to purchase up to 1.50 million additional shares. The IPO is expected to be priced between $14.00 and $16.00 per share.

Underwriters of the IPO:

Citigroup Global Markets Inc., Cowen and Company, LLC, Evercore Group L.L.C., Needham and Company, LLC

Pipeline & Near-term Catalysts:

— The lead wholly owned product candidate is SL-172154, a bi-functional fusion protein that targets CD47 on malignant cells and CD40 on immune cells (antigen presenting cells).

A phase I clinical trial of SL-172154 administered by intravenous injection in patients with ovarian, fallopian tube, and peritoneal cancers, referred to collectively as ovarian cancer is underway, with initial data expected in the second half of 2021.

A phase I clinical trial of SL-172154 administered by intratumoral injection in patients with cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma is expected to be initiated this quarter, with data expected in the second half of 2022.

— Up next is SL-279252, which is in a phase I clinical trial in patients with advanced solid tumors and lymphoma. This compound is being developed in collaboration with Takeda Pharmaceuticals.

Data from the phase I trial of SL-279252 is expected in the second half of 2021.

3. Spruce Biosciences Inc.

Spruce Biosciences, founded in 2014, is a late-stage biopharmaceutical company developing novel therapies for rare endocrine disorders.

The Daly City, California-based company plans to list its stock on the Nasdaq Global Select Market under the symbol “SPRB” on October 9, 2020.

The company has offered to sell 5.0 million shares in the offering – with the initial public offering price expected to be between $14.00 and $16.00 per share. The underwriters have a 30-day option period to purchase up to 750 thousand additional shares.

Underwriters:

Cowen and Company, LLC, SVB Leerink LLC, Credit Suisse Securities (USA) LLC, RBC Capital Markets, LLC

Pipeline & Near-term Catalysts:

The company’s lead product candidate, Tildacerfont, is a non-steroidal, oral antagonist of a protein called the CRF1 receptor, for classic congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS).

A phase IIb trial of Tildacerfont in adult patients with classic CAH with poor disease control, dubbed Study 203, is underway, with topline results expected in Q4,2021/Q1,2022.

A phase IIb trial of Tildacerfont in adult patients with classic CAH with good disease control, dubbed Study 204, is ongoing, with topline results from anticipated in the first half of 2022.

A phase II trial of Tildacerfont in pediatric patients with classic congenital adrenal hyperplasia is expected to be initiated in the second half of 2021.

An Investigational New Drug application to study Tildacerfont in females with a rare form of polycystic ovary syndrome is slated to be submitted to the FDA in the first half of 2021, with initiation of phase II proof-of-concept clinical trial expected in the second half of 2021.

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FDA Approves GlaxoSmithKline’s Nucala To Treat Rare Blood Disorders

The U.S. Food and Drug Administration approved the first drug to treat adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.

GlaxoSmithKline’s Nucala (mepolizumab) is the first FDA-approved drug in nearly 14 years to treat this group of rare and debilitating blood diseases and other rare conditions.

HES is a heterogeneous group of rare disorders associated with persistent eosinophilia (higher than normal levels of a type of disease-fighting white blood cell) with evidence of organ damage. Signs and symptoms vary significantly based on which parts of the body are affected.

Although any organ system can be involved in HES, the heart, central nervous system, skin, and respiratory tract are the most commonly affected.

The approval for Nucala was granted based on the results of a randomized, double-blind, multicenter, placebo-controlled trial in 108 patients with HES. In the study, patients were randomly assigned to receive Nucala or placebo by injection every four weeks. Fewer patients in the Nucala treatment group (28%) had HES flares compared to patients in the placebo group (56%), with a 50% relative reduction.

For the treatment of HES, Nucala received orphan drug designation, which provides incentives to assist and encourage drug development for rare diseases. Additionally, the application was granted fast track designation and priority review.

Nucala is also FDA-approved for patients aged 6 years and older with severe asthma with an eosinophilic phenotype and for adult patients with eosinophilic granulomatosis with polyangiitis, a rare autoimmune condition that causes blood vessel inflammation.

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