The Daily Biotech Pulse: Merck's Oral COVID-19 Pill Authorized In UK, Novartis Cashes Out Of Roche, Chimerix Plunges On Data, Evotec IPO

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

Stocks In Focus

Merck's Oral Antiviral COVID-19 Pill Authorized In UK 

Merck & Co., Inc. MRK and Ridgeback Biotherapeutics announced the U.K. Medicines and Healthcare products Regulatory Agency has granted authorization for molnupiravir, the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. In the U.K., Lagevrio is the planned trademark for molnupiravir.

Merck shares were up 2.04% at $90.49 in premarket trading.

Novartis Cashes Out Of Roche Investment With Rich Returns

Novartis AG NVS said it has decided to sell 53.3 million, or approximately 33%, of Roche Holding AG RHHB bearer shares in a bilateral transaction to Roche for a total consideration of $20.7 billion.

Vas Narasimhan, CEO of Novartis, said: "After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment. Today's announcement is consistent with our strategic focus and we intend to deploy the proceeds from the transaction in line with our capital allocation priorities to maximize shareholder value and continue to reimagine medicine."

Novartis acquired the stake between 2001 and 2003 for a total consideration of approximately $5 billion as a long-term financial investment which delivered significant, recurring earnings contribution and cumulative dividends in excess of $6 billion.

Novartis shares were up 0.44% at $83.96 in premarket trading.

Oyster Point Announces Commercial Availability Of Recently Approved Dry Eye Disease Treatment

Oyster Point Pharma, Inc. OYST announced that Tyrvaya nasal spray 0.03 mg is now available at U.S. regional wholesalers for distribution to pharmacies. The U.S. Food and Drug Administration approved Tyrvaya nasal spray for the treatment of the signs and symptoms of dry eye disease on Oct. 15.

The stock was up 13.5% at $13.50 in premarket trading.

Vaccitech Announces Publication Of Positive Results From Phase 1 Study of MERS Vaccine Candidate

Vaccitech plc VACC announced the publication in the Lancet Microbe, positive results from the first Phase 1 clinical trial conducted in the Middle East evaluating the safety and tolerability of the ChAdOx1 MERS vaccine candidate. The study builds on the first Phase 1 clinical trial of ChAdOx1 MERS conducted in the U.K. and published in Lancet ID last year.

The trial showed that ChAdOx1 MERS was generally well-tolerated, with most adverse events either mild or moderate. The vaccine candidate induced robust antibody and T cell immune responses in all volunteers. Antibodies peaked at day 28 and T cell responses peaked at day 14, both of which were maintained until the end of follow-up at six months. The results of the study support advancing the vaccine candidate into Phase 2 development.

Related Link: The Week Ahead In Biotech (Oct. 31-Nov. 6): Earnings Pick Up Pace, Eton Awaits Seizure Drug Approval, Kidney Conference, More IPOs In The Pipeline

Chimerix Sinks On Safety Concerns Over Its Brain Tumor Treatment Candidate

Chimerix CMRX announced topline data from its 50-patient efficacy analysis of ONC201 for the treatment of recurrent H3 K27M-mutant glioma. An efficacy analysis by blinded independent central review of the registration cohort determined the overall response rate be 20%, median duration of response was 11.2 months and the median time to response was 8.3 months.

One serious adverse event was attributed by an investigator as possibly related to ONC201, the company said. Full safety data collection and analysis for this cohort is ongoing.

The stock was plummeting 26.19% to $4.34 in premarket trading.

Epizyme's Blood Cancer Treatment Candidate Gets Fast Track Designation

Epizyme, Inc. EPZM announced the FDA has granted fast track designation to EZM0414, its investigational agent for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. In addition, the company said it has initiated a Phase 1/1b study to evaluate safety and determine the optimal dose of EZM0414.

Earnings

Supernus Pharmaceuticals, Inc. SUPN's third-quarter revenues declined 4% to $148.5 million. The earnings per share fell from 74 cents to 40 cents. The results were ahead of the expectations. While lowering the high-end of the 2021 revenue guidance, the company increased the operating income guidance.

The stock was up 9.89% at $33 in after-hours trading.

Theravance Biopharma, Inc. TBPH reported third-quarter revenues of $13.2 million, down from $18.26 million last year. The net loss per share, however, narrowed from $1.16 to 48 cents. The results trailed expectations.

The stock was moving down 7.8% to $7.45 in premarket trading.

Gritstone bio, Inc. GRTS's third-quarter revenues climbed from $939,000 in 2020 to $2.61 million in 2021. The net loss per share narrowed from 69 cents to 36 cents. The results exceeded expectations.

The stock was retreating 10.19% to $10.05 in premarket trading.

Tandem Diabetes Care, Inc. TNDM reported third-quarter revenues of $179.63 million, higher than the year-ago's $123.6 million. The company reversed from a loss of 15 cents per share to a profit of 9 cents per share. The company raised its revenue guidance for the full year. The results as well as the guidance were above expectations.

In premarket trading, the stock was trading down 8.61% at $129.23.

Offerings

ANI Pharmaceuticals, Inc. ANIP priced its underwritten public offering of 1.5 million shares of its common stock at a public offering price of $50 per share. The gross proceeds of the offering to the Company are expected to be $75 million.

The stock was slipping 4.48% to $54.12 in premarket trading.

Click here to access Benzinga's FDA Calendar.

On The Radar

Clinical Readouts/Presentations

The American Society of Nephrology Kidney Week 2021 Presentations

Talaris Therapeutics, Inc. TALS: data from continued long-term follow-up of patients treated in the Phase 2 study of FCR001, as well as findings from urinary cell mRNA profiling of a subgroup of those Phase 2 patients

Chinook Therapeutics, Inc. KDNY: initial results of a Phase 1/2 study of BION-1301 in patients with IgA nephropathy.

Vera Therapeutics, Inc. VERA: data for the company's lead product candidate, atacicept, from the Phase 2a JANUS clinical trial in patients with IgA nephropathy.

DiaMedica Therapeutics Inc. DMAC: late-breaking data from the Phase 2 REDUX trial of DM199 in chronic kidney disease.

Dicerna Pharmaceuticals, Inc. DRNA: data from the PHYOX2 trial of nedosiran, an investigational RNAi candidate for the treatment of primary hyperoxaluria.

Earnings

• Zimmer Biomet Holdings, Inc. ZBH (before the market open)
• Regeneron Pharmaceuticals, Inc. REGN (before the market open)
• NeoGenomics, Inc. NEO (before the market open)
• Moderna, Inc. MRNA (before the market open)
• Lantheus Holdings, Inc. LNTH (before the market open)
• Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
• Intellia Therapeutics, Inc. NTLA (before the market open)
• Sangamo Therapeutics, Inc. SGMO (before the market open)
• Jounce Therapeutics, Inc. JNCE (before the market open)
• Fulcrum Therapeutics, Inc. FULC (before the market open)
• Chimerix, Inc. CMRX (before the market open)
• Provention Bio, Inc. PRVB (before the market open)
• Aerie Pharmaceuticals, Inc. AERI (after the close)
• Aligos Therapeutics, Inc. ALGS (after the close)
• Allogene Therapeutics, Inc. ALLO (after the close)
• Global Blood Therapeutics, Inc. GBT (after the close)
• Caladrius Biosciences, Inc. CLBS (after the close)
• Bionano Genomics, Inc. BNGO (after the close)
• Kura Oncology, Inc. KURA (after the close)
• Y-mAbs Therapeutics, Inc. YMAB (after the close)
• Zogenix, Inc. ZGNX (after the close)
• Vir Biotechnology, Inc. VIR (after the close)
• Quidel Corporation QDEL (after the close)
• Puma Biotechnology, Inc. PBYI (after the close)
• Novavax, Inc. NVAX (after the close)
• Nektar Therapeutics NKTR (after the close)
• Natera, Inc. NTRA (after the close)
• Insulet Corporation PODD (after the close)
• Illumina, Inc. ILMN (after the close)
• Guardant Health, Inc. GH (after the close)
• Iovance Biotherapeutics, Inc. IOVA (after the close)
• Collegium Pharmaceutical, Inc. COLL (after the close)
• Globus Medical, Inc. GMED (after the close)
• Glaukos Corporation GKOS (after the close)
• Fate Therapeutics, Inc. FATE (after the close)
• Endo International plc ENDP (after the close)
• Emergent BioSolutions Inc. EBS (after the close)
• Axonics, Inc. AXNX (after the close)
• Arena Pharmaceuticals, Inc. ARNA (after the close)

IPOs

Hamburg, Germany-based Evotec SE EVO priced its downsized initial public offering of 20 million ADSs at $21.75 per ADS. Each ADS represents one-half of one ordinary share. The company is a drug discovery and development partner for the pharmaceutical and biotechnology industry. The offering will produce gross proceeds of $435 million. The shares are expected will begin trading on the Nasdaq under the ticker symbol "EVO."

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