The Daily Biotech Pulse: Moderna Files For 2nd COVID Booster Shot Authorization, Lexicon Secures Debt Funding, Amneal Gets Sub-License to Manufacture Generic COVID Pill

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

Stocks In Focus

Lexicon Clinches Deal to Secure $150M Debt Financing For Supporting Potential Launch Of Heart Failure Drug

Lexicon Pharmaceuticals, Inc. LXRX announced an agreement relating to a loan facility with Oxford Finance for up to $150 million in borrowing capacity. The funding will primarily support commercial preparations and the potential launch of sotagliflozin in heart failure, it added.

Late last month, the company voluntarily withdrew the regulatory application filed with the U.S. Food and Drug Administration for sotagliflozin to correct what it claimed to be a technical flaw. The company also said it targets a resubmission in the second quarter.

The stock was adding 4.55% to $2.30 in premarket trading.

Click here to access Benzinga's FDA Calendar

Moderna Files For Expanding Authorization For Second Booster Dose Of COVID-19 Vaccine

Moderna, Inc. MRNA said it has submitted a request to the FDA for an amendment to the emergency use authorization to allow for a fourth dose of its COVID-19 vaccine in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

This submission is based in part on recently published data generated in the United States and Israel following the emergence of omicron, Moderna said.

Earlier this week, Pfizer, Inc. PFE and BioNTech SE BNTX also applied for authorization of a second booster shot of their co-developed vaccine, Comirnaty.

Moderna shares were rallying 1.20% to $170.28 in premarket trading.

Protalix Announces Positive Phase 3 Data For Fabry Disease Treatment

Protalix BioTherapeutics, Inc. PLX and Chiesi Group announced final results from the BRIGHT Phase 3 clinical trial evaluating pegunigalsidase alfa for the potential treatment of Fabry disease. The results indicate that treatment with 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks was well tolerated, and Fabry disease assessed by estimated glomerular filtration rate slope and plasma lyso-Gb3 concentration was stable.

Amneal Gets Sub-License to Manufacture Generic Version Of Pfizer's Oral COVID Pill

Amneal Pharmaceuticals, Inc. AMRX said it has been awarded a sub-license from the Medicines Patent Pool to manufacture and commercialize a generic version of Pfizer's oral COVID pill Paxlovid, in 95 low- and middle-income countries.

Paxlovid comprises nirmatrelvir, co-packaged with ritonavir for the treatment of mild-to-moderate COVID-19.

The company said it will strive to bring the co-packaged combination to these impacted countries starting in 2023.

Earnings

CymaBay Therapeutics, Inc. CBAY said its fourth-quarter loss widened from 23 cents per share in 2020 to 34 cents per share in 2021 amid higher R&D and interest expenses. Analysts, on average, had estimated a loss of 26 cents per share for the quarter.

The stock was slipping 5.66% to $3 in premarket trading.

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

On The Radar

Clinical Readouts/Presentations

AC Immune SA ACIU will present at the International Conference On Alzheimer's And Parkinson's Diseases And Related Neurological Disorders (AD/PD 2022), Phase 1b data for ACI-24 anti-Abeta vaccine.

Inhibikase Therapeutics, Inc. IKT is scheduled to present at the AD/PD 2022 meeting, preclinical, Phase 1 and Phase 1b data for IkT-148009 for the treatment of Parkinson's disease.

Alkermes plc ALKS is due to present at the Society of American Gastrointestinal And Endoscopic Surgeons 2022 Annual Meeting Phase 3 data for nemvaleukin alfa in combination with Merck & Co., Inc.'s MRK Keytruda versus chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.