The Daily Biotech Pulse: Moderna's Booster Shot Gets FDA Panel Backing, Decision Day For Avadel, Silence Therapeutics Strikes Licensing Deal, MiNK IPO
Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus Adcom Recommends Approval Of Moderna's COVID-19 Vaccine Booster Shot For Use In Select Population
Moderna, Inc. (NASDAQ: MRNA) confirmed the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee recommended that the FDA grant an emergency use authorization for a booster dose of its COVID-19 vaccine at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 whose exposure to COVID-19 puts them at risk for COVID-19 complications or severe illness.
The positive vote was unanimous with 19 VRBPAC members recommending the EUA. The booster dose is to be administered at least six months after completion of the primary series.
This recommendation is in line with prior VRBPAC vote favoring a third dose of Pfizer, Inc. (NYSE: PFE)/BioNTech's (NASDAQ: BNTX) Comirnaty in the same population
Moderna shares were adding 2.93% to $341.59 in premarket trading.
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AstraZeneca Announces Positive Phase 3 Data For Imfinzi Combo In Liver Cancer
AstraZeneca plc (NASDAQ: AZN) announced positive high-level results from the HIMALAYA Phase 3 trial that showed a single, high priming dose of tremelimumab added to Imfinzi demonstrated a statistically significant and clinically meaningful overall survival benefit versus Bayer's (OTC: BAYRY) sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma, who had not received prior systemic therapy and were not eligible for localized treatment.
The combination demonstrated a favorable safety profile, and the addition of tremelimumab to Imfinzi did not increase severe hepatic toxicity.
Imfinzi alone demonstrated non-inferior OS to sorafenib with a numerical trend in favour of Imfinzi and an improved tolerability profile compared to sorafenib.
The stock was up 1.02% at $60.28 in premarket trading.
Silence Announces Agreement to Out-license mRNAi Platform For Up to $1.3B
Silence Therapeutics plc (NASDAQ: SLN) and China's Hansoh Pharma announced a collaboration to develop siRNAs for three undisclosed targets leveraging Silence's proprietary mRNAi GOLD platform.
Hansoh will make a $16 million upfront payment and Silence is eligible to receive up to $1.3 billion in additional development, regulatory and commercial milestones. Silence will also receive royalties tiered from low double-digit to mid-teens on Hansoh net product sales.
Emergent BioSolutions Commences Late-stage Study of Chikungunya Vaccine
Emergent BioSolutions Inc. (NYSE: EBS) announced the first participant has been dosed in its pivotal phase 3 study evaluating the safety and immunogenicity of the its investigational chikungunya virus, virus-like particle vaccine candidate in a single dose.
CHIKV VLP is the only VLP-based vaccine currently in clinical development for active immunization against chikungunya disease.
Sonoma's Nanocyn Disinfectant Gets Expanded Approval In Australia
Sonoma Pharmaceuticals, Inc. (NASDAQ: SNOA) and its partner, the MicroSafe Group, announced that the Australian Therapeutic Goods Administration has approved extended claims for Nanocyn disinfectant and sanitizer, which is manufactured by Sonoma for its partner MicroSafe using Sonoma's patented Microcyn Technology.
After initially approving for use against SARS-CoV-2 in mid-2020, the TGA has now approved extended claims for the hard-surface disinfectant Nanocyn with a 15 second kill time against common viruses, including SARS-CoV-2, Norovirus, and influenza, and a 30-second kill contact time against common bacteria, such as Staphylococcus aureus, E. coli, Pseudomonas aeruginosa, fungi and mold - including Candida Albicans.
The stock was jumping 23.23% to $7.32 in premarket trading.
Lava's Blood Cancer Drug Receives Orphan Drug Designation From FDA
Lava Therapeutics N.V. (NASDAQ: LVTX) announced that the FDA has granted orphan drug designation for its CD1d targeted Gammabody, LAVA-051, for the treatment of chronic lymphocytic leukemia.
The stock was gaining 11.27% to $8.49 in premarket trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates
On The Radar PDUFA Dates
The FDA is scheduled to announce its decision on Avadel Pharmaceuticals plc (NASDAQ: AVDL)'s new drug application for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The decision is due by Friday.
Adcom Meetings
FDA's VRBPAC will discuss amending the emergency use authorization of Johnson & Johnson (NYSE: JNJ) unit Janssen unit's COVID-19 vaccine for administration of a booster dose, in individuals 18 years of age and older.
Clinical Readouts
Applied Molecular Transport Inc. (NASDAQ: AMTI) will provide update on the four ongoing Phase 2 clinical trials for oral AMT-101 at its virtual R&D day, scheduled between 11 am and 1 pm.
Earnings
Biomerica, Inc. (NASDAQ: BMRA) (before the market open)
IPOs
MiNK Therapeutics, Inc. (NASDAQ:MiNK) a clinical stage biotech company developing allogeneic, off-the-shelf, invariant natural killer T cell therapies to treat cancer and other immune-mediated diseases, priced its initial public offering of 3.33 million shares of common stock at $12 per share. The gross proceeds of the offering are expected to be approximately $40 million.
The shares will begin trading on the Nasdaq under the ticker symbol "INKT." All of the shares are being offered by MiNK.
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