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MRKR Soars As FDA Lifts Hold On MT-401, RYTM Sells Priority Review Voucher, MLND Dumps MLE-301

biotech jan06 lt

Today's Daily Dose brings you news about the FDA lifting the partial clinical hold on Marker Therapeutics' phase II post-transplant acute myeloid leukemia trial; Rhythm selling its Rare Pediatric Disease Priority Review Voucher for $100 million; Hoth Therapeutics' financing agreement; Millendo discontinuing further development of MLE-301 for the treatment of menopausal vasomotor symptoms; and Aerpio Pharma exploring strategic alternatives.

Read on…

1. FDA Lifts Partial Hold on Marker's MT-401 Trial

Marker Therapeutics Inc. (MRKR) is all set to move forward with its phase II trial of MT-401 for the treatment of post-transplant acute myeloid leukemia, now that the FDA has lifted the partial clinical hold that was in place since last February.

MT-401 is an allogeneic multi-tumor-associated antigen (MultiTAA)-specific T cell product manufactured under Good Manufacturing Practice (GMP) using donor-derived T cells.

A full clinical hold was imposed on the trial by the FDA on November 12, 2019, seeking additional information and technical specifications for two legacy reagents supplied by third parties used in the MultiTAA-specific T cell manufacturing process. After the company satisfied the Agency's request, the full clinical hold was converted to partial hold last February.

Commenting on the FDA's decision to lift the partial hold Mythili Koneru, Chief Medical Officer of Marker Therapeutics, said, "We are pleased to move forward with our Phase 2 AML trial of MT-401, which we believe may provide a safe and effective treatment option for patients with post-transplant AML over the standard of care."

MRKR closed Tuesday's trading at $1.73, up 17.69%.

2. Rhythm Sells Priority Review Voucher for $100 Mln

Rhythm Pharmaceuticals Inc. (RYTM) has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for $100 million.

The FDA awarded the Priority Review Voucher to Rhythm for securing approval of IMCIVREE last November for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing.

Commenting on the agreement, David Meeker, Chair, President and Chief Executive Officer of Rhythm, said, "The non-dilutive capital from the sale of our PRV provides an important source of additional funding to advance the continued development of Setmelanotide as a precision medicine for people whose severe obesity and insatiable hunger may be caused by genetic variants associated with the melanocortin-4 (MC4R) receptor pathway."

RYTM closed Tuesday's trading at $31.52, up 3.82%.

3. Hoth Therapeutics Secures $5 Mln Financing

Hoth Therapeutics Inc. (HOTH) has entered into a definitive securities purchase agreement in connection with a private placement to institutional investors.

As per the agreement, the investors have agreed to purchase 2.47 million shares of the company's common stock and accompanying warrants to purchase up to an aggregate of approximately 1.24 million shares of common stock, at a purchase price of $2.02 per share and accompanying warrant to purchase 0.5 of a share of common stock, which is at-the-market under Nasdaq rules.

The financing, which is slated to close on January 7, 2021, is expected to bring in gross proceeds of approximately $5.0 million for the company.

Hoth is planning to start preclinical studies of HT-006 for various multi-drug resistant bacterial species this quarter.

HOTH closed Tuesday's trading at $2.30, down 8.37%.

4. Millendo Pulls the Plug on MLE-301

Shares of Millendo Therapeutics Inc. (MLND) plunged more than 17% on Tuesday, following the company's decision to discontinue further development of MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist, for the treatment of menopausal vasomotor symptoms.

The decision to pull the plug on MLE-301 was taken based on an analysis of the pharmacokinetic and pharmacodynamic data from the ongoing phase I study being conducted in healthy male volunteers.

According to the company, while MLE-301 was generally well-tolerated, the data do not support moving forward with its development in the target population of peri- and post-menopausal women, especially with the evolving dynamics of a highly competitive NK3R antagonist market.

To rein in the expenses, the company may also plan for a reduction in its workforce.

MLND closed Tuesday's trading at $1.69, down 17.96%.

5. Aerpio Exploring Strategic Options

Shares of Aerpio Pharmaceuticals Inc. (ARPO) were up over 12% at $1.20 in after-hours Tuesday, on news of the company's decision to explore strategic alternatives focused on maximizing stockholder value.

The strategic options being reviewed by the company include partnering its programs, as well as, the potential for an acquisition, company sale, merger, business combination, asset sale, in-license, out-license or others.

Last month, the company announced statistically significant results from its phase II trial of Razuprotafib in patients with elevated intraocular pressure associated with open angle glaucoma or ocular hypertension.

ARPO closed Tuesday's trading at $1.07, up 1.90%. In after-hours, the stock was up 12.15% at $1.20.

6. Cerecor's COVID Study Meets Key Goal

Cerecor Inc.'s (CERC) exploratory phase II US trial of CERC-002 in patients hospitalized with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome has demonstrated robust improvement in the primary endpoint.

The primary endpoint is the proportion of patients alive and free of respiratory failure over the 28-day study period compared to placebo. The 28-day mortality was reduced by approximately 50% in patients treated with CERC-002 compared to placebo.

The company intends to meet with the FDA and believes that these data support the initiation of a registration trial and filing for Breakthrough Therapy Designation.

CERC closed Tuesday's trading at $2.92, up 10.61%.

7. AbbVie Hands Over Rights of muscarinic agonist program to Sosei

Sosei Group Corp. (SOLTF.OB) has regained the worldwide rights to its muscarinic agonist programs in development for the treatment of major neurological disorders, including Alzheimer's disease from AbbVie (ABBV).

The global rights to the muscarinic receptor agonists were originally handed over by Sosei Group to Allergan in April 2016 under a deal potentially valued at $3.35 billion. Allergan was acquired by AbbVie in May 2020.

The decision of AbbVie to hand over the worldwide rights to muscarinic agonist programs was based on its pipeline strategy and is not as a result of safety or efficacy data.

Sosei said it will now conduct a full internal review to determine a strategy for the further development and re-partnering of the muscarinic agonist programs.

SOLTF.OB closed Tuesday's trading at $16.29, up 3.17%.

8. Stocks That Lost/Gained the Most

Synthetic Biologics Inc. (SYN) closed Tuesday's trading at $1.00, up 99.96%.

ImmunoPrecise Antibodies Ltd. (IPA) closed at $16.73, up 24.85%.

The Ensign Group Inc. (ENSG) closed at a new high of $80.61, up 6.99%.

Bionano Genomics Inc. (BNGO) closed at $4.95, down 31.25%.

Mersana Therapeutics Inc. (MRSN) closed at $18.70, down 29.49%.

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