The Daily Biotech Pulse: KemPharm ADHD Drug Gets The Nod, MediciNova Shelves Vaccine Study - iShares Biotechnology ETF (NASDAQ:IBB)

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 March 2)

Bioanalytical Systems, Inc. BASI
Celldex Therapeutics, Inc. CLDX
Cullinan Oncology, Inc. CGEM
Dicerna Pharmaceuticals Inc DRNA
Exagen Inc. XGN
Fortress Biotech, Inc. FBIO
Gemini Therapeutics, Inc. GMTX
Glaukos Corp GKOS
iTeos Therapeutics, Inc. ITOS
Landos Biopharma, Inc. LABP
MiMedx Group, Inc. MDXG
Organogenesis Holdings Inc ORGO
Pandion Therapeutics Inc PAND
Protagonist Therapeutics, Inc. NASDAQ: (PTGX)
Terns Pharmaceuticals, Inc. TERN
Theratechnologies Inc. THTX
Xenon Pharmaceuticals Inc. XENE (reacted to its fourth-quarter results)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 2)

Karyopharm Therapeutics Inc KPTI
Lucira Health Inc LHDX
Sana Biotechnology, Inc. SANA

Stocks In Focus

Arena Flunks a Mid-stage Study of Olarinab In Treating Abdominal Pain Associated With Irritable Bowel Syndrome

Arena Pharmaceuticals, Inc. ARNA announced topline results from the Phase 2b CAPTIVATE clinical trial evaluating three doses of olorinab, in participants with abdominal pain due to irritable bowel syndrome, showing the investigational asset did not meet the primary efficacy endpoint of statistically significant improvement in the overall average abdominal pain score, or AAPS, from baseline to week 12.

A pre-specified analysis assessed participants with baseline AAPS of 6.5 or more, representing those with moderate to severe pain. This subgroup accounted for 50% of the overall study population. Within this subgroup, the 50 mg treatment group showed a clinically meaningful1 and statistically significant reduction, the company said.

The stock declined 8.87% to $70 in after-hours trading.

KemPharm Gets FDA Nod For its ADHD Drug

KemPharm Inc KMPH announced that FDA has approved the new drug application for Azstarys, formerly referred to as KP415, a once-daily product for the treatment of attention deficit hyperactivity disorder in patients age six years and older. It contains serdexmethylphenidate, KemPharm's prodrug of d-methylphenidate.

KemPharm is collaborating with Aquestive Therapeutics Inc AQST for an oral film dosage of KP415.

KemPharm shares were jumping 71.37% to $16.16 in premarket trading Wednesday, while Aquestive was advancing 13.05% to $5.63.

Merck to Lend Manufacturing Support For COVID-19 Vaccine

Merck & Co., Inc. MRK announced multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19 medicines and vaccines. The BARDA will provide Merck with funding of up to $268.8 million to adapt and make available a number of existing manufacturing facilities for the production of SARS-CoV-2/COVID-19 vaccines and medicines.

Merck has also entered into agreements with Johnson & Johnson's JNJ Janssen unit to support the manufacturing and supply of Johnson & Johnson's SARS-CoV-2/COVID-19 vaccine. Merck will use its facilities in the U.S. to produce drug substance, formulate and fill vials of Johnson & Johnson's vaccine.

Amgen Announces Publication of Positive Late-stage Data For Blincyto In Blood Cancer

Amgen Inc. AMGN announced publication in the Journal of American Medical Association positive data from a Phase 3 study evaluating the efficacy, safety and tolerability of Blincyto compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia.

Blincyto demonstrated significantly prolonged event-free survival compared with chemotherapy. After a median of 22.4 months follow-up, 69% of Blincyto-treated patients treated were alive and event-free compared with 43% of patients treated with chemotherapy. Additionally, 93% of patients with MRD at baseline achieved MRD negative remission compared with 24% of patients treated with chemotherapy. The 36-month overall survival estimate in the Blincyto group was 81.1% versus 55.8% in the chemotherapy group, and the median OS has not been met.

Sorrento Gets FDA Nod to Commence Phase 1 Study of Intranasal Formulation of Anti-COVID Antibody

Sorrento Therapeutics, Inc. SRNE said it has received clearance from the FDA for its investigational new drug application for its Phase 1 study of the safety and pharmacokinetics of intranasal STI-2099 (COVIDROPS) in both healthy volunteers and patients with mild COVID-19.

Sorrento said it is currently evaluating an intravenous formulation of this potent antibody, STI-2020 in a Phase 1 study in healthy volunteers and COVID-19 patients with mild symptoms. This small volume IV-push formulation is being tested against the dominant strain of the SARS-CoV-2 virus in the U.S. as well as the emerging UK variant.

Sorrento said it now expects to evaluate STI-2099, intranasal formulation, alone or in combination with STI-2020 to treat newly diagnosed patients.

The stock gained 5.19% to $9.93 in after-hours trading.

Boston Scientific to Buy Surgical Business of Lumenis For $1.07B In Cash

Boston Scientific Corporation BSX said it has entered into a definitive agreement with an affiliate of Baring Private Equity Asia to acquire the global surgical business of Lumenis, a privately-held company that develops and commercializes energy-based medical solutions, for an upfront cash payment of $1.07 billion, subject to closing adjustments.

MediciNova to Discontinue Development of COVID-19 Vaccine

MediciNova, Inc. MNOV said it has decided to discontinue development of a SARS-CoV-2 vaccine for COVID-19 in order to maintain adequate resources for its other development programs which have indications with larger unmet medical needs and market opportunities.

The stock was slipping 5.44% to $5.39 in premarket trading Wednesday.

Morphosys Gets 16M-euro Milestone Payment From GlaxoSmithKline For Out-licensed COVID-19 Drug

MorphoSys AG MOR said its licensing partner GlaxoSmithKline plc SK reported positive preliminary results of the OSCAR study that is evaluating otilimab for the treatment of severe pulmonary COVID-19 related disease.

Given these data suggest an important clinical benefit in a pre-defined sub-group of high-risk patients and the urgent public health need, GlaxoSmithKline said it has amended the OSCAR study to expand this cohort to confirm these potentially significant findings.

This event of the first patient dosed in the expanded study triggers milestone payments of a total of 16 million euros to MorphoSys.

Takeda Secures Global Rights to Epilepsy Drug From Ovid For Up to $854M

Takeda Pharmaceutical Company Limited TAK announced an exclusive agreement with Ovid Therapeutics Inc. OVID, under which Takeda will secure global rights at closing from Ovid to develop and commercialize the investigational medicine soticlestat for the treatment of developmental and epileptic encephalopathies, including Dravet syndrome and Lennox-Gastaut syndrome.

Ovid will receive an upfront payment of $196 million at closing and is eligible to receive up to an additional $660 million upon achieving development, regulatory and sales milestones. In addition, Ovid will receive tiered royalties beginning in the low double-digits and up to 20 percent on sales of soticlestat, if approved and commercialized. The new agreement is expected to close by end of March 2021.

Takeda was adding 2.09% to $17.60 in premarket trading Wednesday, while Ovid shares were rallying 89.86% to $5.62.

Exicure Gets Orphan Drug Designation For Cancer Drug

Exicure, Inc. XCUR said the FDA has granted orphan drug designation for its clinical product candidate, cavrotolimod, for the treatment of patients with Merkel cell carcinoma.

In premarket trading Wednesday, the stock was moving 7.93% higher at $2.45.

Earnings

Maravai LifeSciences Holdings, Inc. MRVI said its fourth-quarter revenues climbed 173.5% to $98.4 million. The company reversed from a loss of 3 cents per share to a profit of 13 cents per share, ahead of the consensus estimate of 11 cents per share.

The stock rallied 19.94% to $42.05 in after-hours trading.

Offerings

Nurix Therapeutics, Inc. NRIX said it has commenced an underwritten public offering of 4 million shares of its common stock. All of the shares of common stock are being offered by Nurix.

The stock slipped 2.53% to $35 in after-hours trading.

On The Radar

Earnings

IVERIC bio, Inc. ISEE
Taysha Gene Therapies, Inc. TSHA
Strongbridge Biopharma plc SBBP (before the market open)
OptiNose Inc OPTN (before the market open)
Passage Bio PASG (before the market open)
Ampio Pharmaceuticals, Inc. AMPE

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