The Daily Biotech Pulse: Adamas Rallies On FDA Acceptance, Oxford Immunotech Reportedly Gets $400M Bid

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 4)

• Biohaven Pharmaceutical Holding Co Ltd BHVN
• argenx SE – ADR ARGX
• BioMarin Pharmaceutical Inc. BMRN
• BioXcel Therapeutics Inc BTAI
• Imara Inc IMRA
• Inari Medical Inc NARI
• Intellia Therapeutics Inc NTLA
• ORIC Pharmaceuticals Inc ORIC
• Passage Bio Inc PASG
• Qiagen NV QGEN
• Replimune Group Inc REPL
• Zentalis Pharmaceuticals Inc ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 4)

• Evofem Biosciences Inc EVFM(priced its 28.5 million common stock offering)
• Iterum Therapeutics PLC ITRM

Stocks In Focus

Adamas' Regulatory Application For Label Expansion For Parkinson's Drug Accepted For Review

Adamas Pharmaceuticals Inc ADMS said the FDA has accepted its sNDA for Gocovri as a treatment for OFF episodes in Parkinson's disease patients receiving levodopa-based therapy. The company said the anticipated PDUFA action date is Feb. 1, 2021.

Gocovri has already been approved for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

The stock rallied 18.56% to $3.13 in after-hours trading.

Oxford Immunotech Approached With $400M Bid

Medical diagnostics company Oxford Immunotec Global PLC OXFD is being approached with a $15 per share or a $400 million offer by a consortium of private equity investors led by KKR and Ampersand Capital Partners, Reuters reported.

The company had apparently approached several health care peers in the past year but was unsuccessful in striking a deal.

The stock climbed 15.74% to $15 in after-hours trading.

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

AbbVie Forges Partnerships With 3 Institutions For Developing COVID-19 Antibody Treatment

AbbVie Inc ABBV announced a collaboration with Harbour BioMed, Utrecht University and Erasmus Medical Center to develop a novel antibody therapeutics to prevent and treat COVID-19, the pandemic respiratory disease caused by the SARS-CoV-2 virus.

The collaboration plans to study the fully human, neutralizing antibody 47D11 discovered by institutions that targets the conserved domain of the spike protein of SARS-CoV-2.

AbbVie will support preclinical activities, while also preparing for later stage preclinical and clinical development work. The company has received an exclusive option for licensing the candidate.

Merck Gets FDA Approval For Triple-combo Antibiotic To Treat Hospital-Acquired Pneumonia

Merck & Co., Inc. MRK announced FDA approval of its Recarbrio – a triplet combination of imipenem-cilastatin and relebactam - to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients 18 years of age and older.

Novartis Announces Positive Results For Asthma Study

Novartis AG NVS announced publication of full results from the Phase 3b ARGON study in Respiratory Medicine, which showed once-daily treatment with single inhaler, high- and medium-dose Enerzair Breezhaler demonstrated non-inferiority to a free combination of twice-daily, high-dose salmeterol xinafoate/fluticasone propionate, plus once-daily tiotropium, delivered in two different devices, in improving quality of life in people with uncontrolled asthma.

Among secondary analyses, improvements in lung function, asthma control, health status, and reductions in moderate exacerbations were observed with high-dose once-daily IND/GLY/MF compared to high-dose Sal/Flu plus Tio, the company said.

PDS Biotech To Evaluate Lead Asset In Mid-Stage Study In Cervical Cancer

PDS Biotechnology Corp PDSB announced a Phase 2 clinical trial to evaluate its lead immunotherapy product, PDS0101, in combination with standard of care chemoradiotherapy for treatment of locally advanced cervical cancer.

PDS101, according to the company, is being developed for multiple cancers associated with HPV infection, including anal, cervical and head and neck cancers. Results of a Phase 1 trial released in Sept. 2019 showed the investigational asset demonstrated potent in vivo induction of active killer T-cells that target cancer cells containing the cancer-causing HPV proteins, as well as an excellent safety profile with no limiting toxicities.

Offerings

Menlo Therapeutics Inc MNLO said it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering

The stock slipped 14.03% to $1.90 in after-hours trading.

On The Radar

IPOs

Applied Molecular Transport, a clinical-stage biopharma, priced its upsized initial public offering, or IPO, of 11 million shares at $14 per share compared to the initially estimated range of $12-$14. The shares will begin trading on the Nasdaq under the ticker symbol AMTI.

Stockholm, Sweden-based specialty pharma company Calliditas Therapeutics priced its IPO of 9.231 million shares, consisting of a public offering of 8.317 million ADSs, with each ADSs representing two common shares, and a concurrent private placement of 924,000 common shares to certain qualified investors in Europe and certain other jurisdictions outside of the U.S. The company expects to raise gross proceeds of $90 million from the offering. The offering was upsized from the initial plan of an offering worth $75 million. The shares will commence trading on the Nasdaq under the ticker symbol CALT.