The Daily Biotech Pulse: Moderna, Pfizer-BioNTech Ink New Vaccine Deals With UK, GSK-Vir Antibody Show Activity Against Omicron, Chemomab Gets Clearance

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

U.K. Signs Deal to Buy Incremental COVID-19 Vaccines From Moderna And Pfizer-BioNTech

Moderna, Inc. MRNA announced a revised supply agreement with the U.K. government for up to 60 million doses of its COVID-19 vaccine, which may include authorized booster vaccine candidates. The U.K. government has also signed a new contract with Pfizer, Inc. PFE-BioNTech SE BNTX to secure an additional 54 million doses of their vaccine, named Comirnaty.

Moderna shares were down 3.87% at $298.59 in premarket trading. Pfizer shares were slipping 1.06% to $54.10 and BioNTech was retreating 3.44% to $322.99 .

Amgen's Otezla Meets Primary And Secondary Endpoints In Late Stage Study In Patients With Genital And Plaque Psoriasis

Amgen, Inc. AMGN announced positive top-line results from the DISCREET Phase 3 study to assess the efficacy of Otezla in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis.

The study showed that oral Otezla 30 mg twice daily achieved a clinically meaningful and statistically significant improvement, compared with placebo, in the primary endpoint of the modified static Physician's Global Assessment of Genitalia response at week 16. The study also met all the secondary endpoints.

The stock was up 0.52% at $201.85 in premarket trading.

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Fulgent Says Its RT-PCR Test Can Detect Omicron Variant

Fulgent Genetics, Inc. FLGT confirmed that its RT-PCR test for SARS-CoV-2 can successfully detect the recently emerged omicron variant of the virus. In addition, Fulgent also expressed confidence that its next-generation sequencing tests for COVID-19 can accurately identify the variant.

The stock was advancing 1.30% at $85 in premarket trading.

Acasti Announces Positive Results For Pivotal Pharmacokinetic Bridging Study Of Drug To Treat Bleeding Over Brain Surface

Acasti Pharma Inc. ACST announced positive results for GTX-104 based on its interim analysis of the first 20 of 50 normal healthy subjects in its pivotal pharmacokinetic bridging study. GTX-104 met both primary endpoints for maximum concentration on Day 1 and area under the concentration-time curve, allowing the study to continue under the current infusion protocol to its completion.

GTX-104 is an aqueous formulation of nimodipine developed as an IV infusion for patients experiencing subarachnoid hemorrhage, or bleeding over the surface of the brain triggered by a ruptured aneurysm.

In premarket trading, the stock was rallying 11.81% to $1.42.

GSK, Vir COVID-19 Antibody Treatment Retains Activity Against Key Mutations Of The Omicron Variant In Animal Study

GlaxoSmithKline plc GSK and Vir Biotechnology, Inc. VIR announced an update to bioRxiv, a preprint server, with preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains activity against key mutations of the new omicron SARS-CoV-2 variant, including those found in the binding site of sotrovimab.

These data were generated through pseudo-virus testing of specific individual mutations found in Omicron.

The companies are now completing in vitro pseudo-virus testing to confirm the neutralizing activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.

Vir shares were rising 9.54% to $51.45 in premarket trading and GSK was 0.41% to $41.54.

Chemomab Gets FDA Clearance For Commencing U.S. Phase 2 Study Of Bile Duct Disease Treatment

Chemomab Therapeutics, Ltd. CMMB announced that the U.S. Food and Drug Administration has cleared its investigational new drug application for CM-101 for the treatment of the rare disease primary sclerosing cholangitis.

The Phase 2 SPRING trial assessing CM-101 as a potential treatment for PSC is already underway in Europe and Israel and is now being expanded to include U.S. sites.

The stock was surging 22.18% to $10.30 in premarket trading.

Novartis Sees 4% CAGR Sales Growth Through 2026

At an investor event, Novartis AG NVS said it is building depth in its core therapeutic areas and strength across key technology platforms. The company said it expects to continue delivering strong operational performance, with 4%+ CAGR through to 2026, driven by the momentum of its multi-billion dollar in-market growth drivers. Up to 20 new assets with significant sales potential could be approved by 2026, it added.

The company also announced a global co-development and co-commercialization agreement with UCB to bring disease-modifying therapies to people living with Parkinson's Disease.

Management Changes

Titan Medical Inc. TMDI announced that President and chief executive officer David McNally has stepped down from both positions, and resigned from the board, effective Wednesday. Paul Cataford, Chair of the board, has been appointed interim President and CEO and Anthony Giovinazzo will assume the role of Lead Independent Director of the board. The company said its board intends to commence a search process in early 2022 to identify a permanent CEO.

Spectrum Pharmaceuticals, Inc. SPPI announced that Tom Riga, currently chief commercial and chief operating officer, will be the next President and CEO, effective Dec. 31. This follows the incumbent Joseph Turgeon, announcing his retirement on Dec. 31 after nine years with the company.

Taro Pharmaceutical Industries Ltd. TARO announced the appointment of William Coote as Vice President, chief financial officer and chief accounting officer, effective Wednesday. Coote was most recently serving as Taro's AVP, Treasurer and Business Finance since 2008.

Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates

On The Radar

Clinical Readouts

Delcath Systems, Inc. DCTH is scheduled to host a comprehensive investor update between 10 a.m. and 1 p.m., wherein it's expected to present Phase 3 efficacy and safety results for Melphalan in liver-dominant ocular melanoma.


Veru, Inc. VERU (before the market opens)

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