The Daily Biotech Pulse: BioXcel's Igalmi Gets FDA Nod, Citius Spikes On Positive Phase 3 Data, Iovance Receives Positive Regulatory Feedback For Skin Cancer Therapy

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

Stocks In Focus

Iovance Plans to File For Melanoma Therapy Approval In August Following Positive FDA Feedback

Iovance Biotherapeutics, Inc. IOVA said the U.S. Food and Drug Administration on Friday provided a positive feedback regarding its proposed matrix of potency assays for its upcoming biologics license application for lifileucel in metastatic melanoma. Based on this response, Iovance expects to request a pre-BLA meeting in July and to complete a BLA submission for lifileucel by August 2022.

The company also announced plans to start a Phase 3 study for lifileucel in combination with Merck & Co., Inc's MRK Keytruda for the treatment of immune checkpoint inhibitor-naïve frontline metastatic melanoma in late 2022.

The stock was adding 4.11% to $17.24 in premarket trading.

Kintor Announces Positive Phase 3 Results For COVID-19 Treatment Candidate

Chinese biopharma Kintor Pharmaceutical Limited KNTPF announced positive topline results from a Phase 3 study of proxalutamide in outpatients with mild-to-moderate COVID-19, regardless of vaccination status and risk factors.

Data from the study demonstrated that the protection rate of patients in the trial treated with proxalutamide for more than seven days reached 100%. The treatment with proxalutamide also significantly reduced hospitalization or death in COVID-19 patients, especially in the middle-aged and elderly with high-risk factors.

Hong Kong-listed shares of Kintor more than doubled earlier on Wednesday.

Click here to access Benzinga's FDA Calendar

Novartis' Sandoz Unit Extends Collaboration For Digital Solutions to Fight Antimicrobial Resistance

Novartis AG's NVS Sandoz generic unit said it is extending the existing master services agreement with Ares Genetics, to develop digital platform for development and life cycle management of antibiotics, to Jan. 31, 2025. The collaboration focuses on next-gen sequencing and AI-assisted bioinformatics solutions for surveillance and drug repurposing efforts.

BeiGene Says Licensing Partner Novartis' Regulatory Applications For Cancer Drug Accepted For Review In Europe

BeiGene Ltd. BGNE said the European Medicines Agency has validated the marketing authorization applications for tislelizumab submitted by the license holder Novartis. The Swiss pharma giant is seeking approval for the drug to treat patients with advanced or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy and patients with non-small cell lung cancer.

BioXcel's Igalmi Approved for Treating Agitation Associated With Neuropsychiatric Disorders

BioXcel Therapeutics, Inc.'s BTAI said the FDA has approved its new drug application for BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. The company said it is prepared to launch the treatment under the brand name Igalmi in the U.S. in the second quarter.

Incyte's Out-licensed Biliary Tract Cancer Drug Approved In China

Chinese biopharma Innovent Biologics, Inc. IVBXF announced that China's National Medical Products Administration has approved Pemazyre for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy.
Pemazyre has been discovered by Incyte Corporation INCY and is licensed to Innovent for development and commercialization in the Greater China region.

Sellas' Chinese Partner Gets Nod to Commence Phase 1 Study Of Tumor Treatment Candidate In China

SELLAS Life Sciences Group, Inc. SLS announced that an investigational new drug application to initiate the first clinical trial in China for 3D189, also known as galinpepimut-S, has been approved by China's NMPA. The IND was submitted by the company's Chinese partner 3D Medicines.

The approval of the IND by the NMPA triggered a $1 million milestone payment to Sellas, which it expects to receive in the second quarter of 2022.

Citius Announces Positive Phase 3 Data For New Formulation Of ONTAK In Blood Cancer, to File For Regulatory Approval In H2

Citius Pharmaceuticals, Inc. CTXR reported topline results from the pivotal Phase 3 trial of I/ONTAK, which is being evaluated for persistent or recurrent cutaneous T-cell lymphoma.

The topline results for I/ONTAK, a purified and more bioactive formulation of previously marketed ONTAK, were consistent with the prior formulation. Moreover, no new safety signals were identified. Based on this data, Citius said it anticipates filing a BLA with the FDA in the second half of 2022.

The shares were jumping 19.02% to $2.19 in premarket trading.

C4 Therapeutics Gains On Insider Buying

C4 Therapeutics, Inc. CCCC shares are gaining ground after the company disclosed in a filing that three of its directors elected to receive their compensation in the form of company's common stock instead of cash.

The stock was adding 4.09% to $22.90 in premarket trading.

Related Link: The Week Ahead In Biotech BioXcel FDA Decision, Neurology Conference Presentations Take The Spotlight

On The Radar

Clinical Readouts/Presentations

Relmada Therapeutics, Inc. RLMD will present data related to REL-1017, its lead product candidate being evaluated in major depressive disorder, in a oral presentation at the Ketamine & Related Compounds International Hybrid Conference 2022. The conference is being held virtually and in Oxford, U.K. (10:30 am ET-11 am ET)

American Academy of Neurology Annual Meeting Presentations

Satsuma Pharmaceuticals, Inc. STSA: Phase 3 data for STS101 in migraine

Longboard Pharmaceuticals, Inc. LBPH: single ascending dose and multiple ascending dose data from the Phase 1 study evaluating LP352 in healthy volunteers

Scholar Rock Holding Corporation SRRK: Phase 2 data for apitegromab in patients with Types 2 and 3 spinal muscular atrophy (Wednesday)

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