CHMA - CHMA STOCK NEWS

Pulmatrix, Inc. (NASDAQ: PULM) announced the appointment of Anand Varadan to its Board of Directors, effective July 26, 2021. Varadan, currently Chief Commercial Officer at Chiasma (NYSE: CHMA), brings valuable commercialization experience. He replaces Mark Iwicki, who resigned on July 23, 2021. CEO Ted Raad expressed optimism about Varadan's contribution to Pulmatrix, focusing on its patented iSPERSE™ technology for inhaled therapies aimed at various diseases. Pulmatrix continues its mission to innovate in pulmonary and non-pulmonary therapies.

Chiasma, Inc. (NASDAQ: CHMA) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA®, an oral therapy for adults with acromegaly. This submission is backed by the successful Phase 3 MPOWERED™ trial, which demonstrated non-inferiority to injectable treatments. MYCAPSSA, the first oral somatostatin analog approved by the FDA, aims to provide a less burdensome alternative for patients. Chiasma estimates around 8,000 adult acromegaly patients are treated with injections in the U.S.

Chiasma presented data from its MPOWERED™ Phase 3 trial demonstrating significant improvements in patient-reported outcomes (PROs) for acromegaly patients switching from injectable somatostatin analogs (iSSAs) to MYCAPSSA®. Conducted with 146 patients, results showed enhanced quality of life and work productivity. Key metrics indicated a mean change of 0.053 in EQ-5D-5L and notable improvements in presenteeism and productivity loss at P=0.024. The trial supports MYCAPSSA as a viable, home-administered treatment option, potentially establishing it as the new standard of care for acromegaly.

Chiasma, Inc. (NASDAQ: CHMA) has announced the acceptance of new clinical data for oral and e-Poster presentations at upcoming endocrinology meetings: the 23rd European Congress of Endocrinology (May 22-26, 2021) and the 30th Annual American Association of Clinical Endocrinology (AACE) Meeting (May 26-29, 2021). The presentations will feature findings from the MPOWERED Phase 3 trial, focusing on the efficacy of oral Octreotide capsules in treating acromegaly. This trial supports MYCAPSSA's ongoing development as a treatment alternative to painful injections, enhancing patient quality of life.

Chiasma, Inc. (CHMA) announced a merger agreement with Amryt Pharma, aimed at creating a leader in rare and orphan disease therapies. For Q1 2021, Chiasma reported net product revenues of $1.9 million, reflecting a 100% increase from Q4 2020. The company achieved payor coverage of MYCAPSSA for over 185 million lives and submitted an IND application for MYCAPSSA in carcinoid syndrome patients. However, Q1 net loss was $30.5 million, a rise from $15.4 million in Q1 2020, while cash reserves decreased to $115 million.

Amryt has announced a definitive agreement to acquire Chiasma in an all-stock transaction, enhancing its position in rare diseases. The combined entity will feature three approved commercial products and a strong pipeline, including MYCAPSSA® and Oleogel-S10, which is under regulatory review. This acquisition is projected to generate approximately $50M in annual cost synergies and pave the way for potential peak revenues of $1BN. Amryt shareholders will own approximately 60% post-transaction, with Chiasma shareholders owning 40%. The deal is expected to close in Q3 2021, pending shareholder and regulatory approvals.

Chiasma, Inc. (NASDAQ: CHMA) will hold a live conference call and audio webcast on May 6, 2021, at 5:00 PM ET to discuss its financial results for Q1 2021 and provide a business update. The call can be accessed domestically at 800-909-4761 and internationally at 312-281-2942, with Conference ID 21993564. An archived replay of the call will be available on Chiasma's website. The company focuses on developing oral therapies for patients with chronic diseases, having received FDA approval for MYCAPSSA, the first oral somatostatin analog, in June 2020.

Chiasma presented positive long-term data from the 48-week open-label extension of the Phase 3 CHIASMA OPTIMAL trial for MYCAPSSA at ENDO 2021. Notably, 93% of responders maintained their biochemical response, with average IGF-1 levels remaining stable. The safety profile was consistent with earlier results, indicating a potential shift toward MYCAPSSA as the standard care for acromegaly patients. The trial involved 56 participants and was designed to assess the efficacy of oral octreotide compared to placebo.

Chiasma's recent press release highlights positive outcomes from the MPOWERED Phase 3 trial of MYCAPSSA for treating acromegaly. The data shows that MYCAPSSA is non-inferior to long-acting injectable somatostatin receptor ligands (iSRLs) in maintaining biochemical responses, with 91% of patients achieving insulin-like growth factor 1 (IGF-1) levels within range. Significant improvements in acromegaly symptoms and patient satisfaction were noted, supporting the potential of MYCAPSSA as a preferred oral therapy. A marketing authorization application to the European Medicines Agency is planned for mid-2021.