SELB Down But Not Out, PFE Takes 9.9% Stake In CStone, ZSAN Plunges, AMAG On The Block?

biotech oct01

Today's Daily Dose brings you news about AMAG reportedly in talks with Covis Pharma about being acquired, Iterum's progress with Sulopenem, Pfizer's stake in CStone, Selecta's Gout trial results, and FDA notification to Zosano over migraine treatment Qtrypta.

Read on…

1. Has AMAG Pharma Put Itself On The Block?

Shares of AMAG Pharmaceuticals Inc. (AMAG) were up over 43% in extended trading Wednesday, following a Bloomberg report that the company is in talks with Covis Pharma about getting acquired.

AMAG is a commercial-stage biopharmaceutical company that has two marketed products - Makena, a long acting form of natural progesterone for the prevention of preterm birth in pregnant women, and Feraheme, an iron replacement therapy for the treatment of iron deficiency anemia in adult patients.

In the second quarter of 2020, revenue totaled $52.8 million compared to $77.8 million for the same period in 2019.

AMAG closed Wednesday's trading at $9.40, up 1.40%. In after-hours, the stock was up 43% at $13.50.

. Iterum to Proceed With Sulopenem NDA Submission

Iterum Therapeutics plc (ITRM) has decided to proceed with an NDA submission for Sulopenem, a bilayer tablet, for the treatment of uncomplicated urinary tract infections in patients with a quinolone-resistant pathogen.

The company announced topline phase III results of Sulopenem in complicated urinary tract infection and uncomplicated urinary tract infection in June this year. While the uncomplicated urinary tract infection trial produced mixed results, the complicated urinary tract infection trial failed to achieve the primary endpoint.

A meeting with the FDA to discuss the regulatory filing of Sulopenem was held by the company recently, following which the decision to go ahead with the NDA submission of Sulopenem for the treatment of uncomplicated urinary tract infections has been taken.

ITRM closed Wednesday's trading at $1.05, up 62.94%.

3. Pfizer Takes 9.9% Stake in CStone

Pfizer Inc. (PFE) has agreed to invest $200 million in CStone Pharmaceuticals (CSPHF.OB), and take a 9.90 percent stake in this China-based biopharmaceutical company.

The strategic collaboration between the two companies is for the development and commercialization of CStone's late-stage oncology asset Sugemalimab in mainland China. Sugemalimab is under four phase III registrational studies, respectively, for stage III/IV non-small cell lung cancer, gastric cancer, and esophageal cancer, among other trials.

As part of the collaboration, Pfizer obtains exclusive commercialization rights to Sugemalimab in mainland China, while CStone continues to lead clinical development and regulatory strategy for five selected indications.

CStone is entitled to receive up to $280 million in milestone payments for Sugemalimab and additional tiered royalties. All development and commercialization rights to Sugemalimab outside mainland China will be retained by CStone.

CSPHF.OB closed Wednesday's trading at $1.36, up 23.64%.

4. COMPARE Gout Trial Misses Key Goal, But Selecta Confident in SEL-212's Potential

Shares of Selecta Biosciences Inc. (SELB) took a hit in extended trading Wednesday on news of the company's phase II chronic refractory gout trial, dubbed COMPARE, failing to meet the primary endpoint of statistical superiority.

The COMPARE trial compared the efficacy of Selecta's SEL-212 against the approved gout drug KRYSTEXXA in the treatment of chronic refractory gout. The primary endpoint measure was a comparison of the percentage of patients on SEL-212 versus KRYSTEXXA who achieved and maintained a reduction of serum uric acid less than 6 mg/dL for at least 80% of the time during months three and six combined. Gout is characterized by elevated levels of uric acid in the blood.

According to the trial results, 59% of patients in the SEL-212 arm had serum uric acid less than 6 mg/dL for at least 80% of the time during months three and six combined compared to 46% in the KRYSTEXXA arm. Although SEL-212 showed a numerically higher response rate on the primary endpoint, it failed to achieve statistical significance.

That said, there was a statistically significant greater overall reduction in mean serum uric acid levels in the SEL-212 arm compared to the KRYSTEXXA-treated arm.

SEL-212 has been licensed to Swedish Orphan Biovitrum AB, also known as Sobi, with Sobi undertaking development, regulatory and commercial activities in all markets outside of China.

Last week, the companies initiated two double-blinded, placebo-controlled phase III clinical trials of SEL-212 for the treatment of chronic refractory gout, dubbed DISSOLVE I, and DISSOLVE II. The topline data from the DISSOLVE program is expected in the second half of 2022, and a Biologics License Application (BLA) filing is expected in the first quarter of 2023.

Commenting on the COMPARE trial data, Carsten Brunn, President and CEO of Selecta, said, "We believe SEL-212, if approved, could improve the lives of patients with chronic refractory gout, as data suggest that SEL-212 addresses several key unmet needs, including the potential to provide a persistent and significant reduction in SUA levels with a convenient monthly treatment".

SELB closed Wednesday's trading at $2.48, down 3.12%. In after-hours, the stock was down 40.32% at $1.48.

5. FDA Notification Gives Zosano Pharma Headaches

Shares of Zosano Pharma Corp. (ZSAN) plunged more than 50 percent in after-hours trading on Wednesday, following a disappointing notification from the FDA related to the company's 505(b)(2) New Drug Application for migraine treatment Qtrypta.

The FDA has raised two concerns with respect to the clinical pharmacology section of the Qtrypta NDA as a result of which the product may not be approved on the assigned decision date of October 20.

Qtrypta, proposed for the acute treatment of migraine, is a proprietary formulation of Zolmitriptan, administered via the company's intracutaneous microneedle-array drug-delivery system. Zolmitriptan as a tablet and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) is already used to treat acute migraine headaches in adults.

In its notification to the company, the FDA has raised questions regarding unexpected high plasma concentrations of Zolmitriptan observed in five study subjects from two pharmacokinetic studies and the differences in Zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company's clinical trials.

ZSAN closed Wednesday's trading at $1.62, up 1.25%. In after-hours, the stock fell 51.55% to $0.78.

6. Stocks That Moved On No News

I-Mab (IMAB) closed Wednesday's trading at $47.03, up 22.54%.

Enlivex Therapeutics Ltd. (ENLV) closed Wednesday's trading at $5.94, up 20.98%.

Renalytix AI plc (RNLX) closed Wednesday's trading at $12.20, up 22.74%.

Aptorum Group Limited (APM) closed Wednesday's trading at $2.68, down 43.70%.

Adial Pharmaceuticals Inc. (ADIL) closed Wednesday's trading at $2.23%, down 26.40%.

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