Allena Pharmaceuticals appoints Mark Fitzpatrick on board of directors » 08:1304/0704/07/21
Allena Pharmaceuticals (ALNA) announced the appointment of Mark Fitzpatrick to its board of directors. Fitzpatrick brings over 30 years of operational and financial management experience to Allena. Most recently, he spent six years at Chiasma (CHMA) where he served initially as Chief Financial Officer and subsequently President and Chief Executive Officer, and played an integral role in securing Food and Drug Administration approval of Mycapssa for the treatment of acromegaly. In conjunction with Mr. Fitzpatrick's appointment, Allena announced that board members James Topper, M.D., Ph.D., a founding member of the company's board of directors since 2011, and Andrew Hack, M.D., Ph.D., a member of the company's board of directors since 2018, will not stand for re-election at the company's annual meeting in June.
|Over a week ago|
Fly Intel: Pre-market Movers » 08:5603/2303/23/21
EHTH, BLFS, ORMP, FREQ, IONS, RHHBY, MP, QS, CHMA
Check out this morning's…
Chiasma presents long term safety, efficacy data for Mycapssa » 16:0403/2203/22/21
Chiasma presented long-term safety and efficacy data from the first 48 weeks of the open-label extension, OLE, of the Phase 3 CHIASMA OPTIMAL trial of Mycapssa at the Endocrine Society's annual meeting, ENDO 2021, being held virtually March 20-23. "These long-term safety and efficacy data demonstrate that MYCAPSSA maintains insulin-like growth factor 1 (IGF-1) levels in patients with acromegaly who previously required monthly injections for their disease," said Susan Samson, M.D., Ph.D., FRCPC, FACE, principal investigator of the trial. "The fact that 90% of the patients receiving MYCAPSSA in the CHIASMA OPTIMAL trial elected to enroll in the OLE demonstrates strong patient preference for MYCAPSSA." Raj Kannan, CEO of Chiasma, added, "The long-term durability of response seen with the 48-week open label extension study further supports our belief in MYCAPSSA's potential to become the new standard of pharmacological care for patients with acromegaly."
Chiasma presents new data for MYCAPSSA from Phase 3 trial MPOWERED » 13:5703/2103/21/21
Chiasma announced the…
Chiasma announced the presentation of new positive clinical data from its MPOWERED Phase 3 trial of MYCAPSSA at the Endocrine Society's annual meeting, ENDO 2021, being held virtually March 20-23, 2021. The data from MPOWERED showed that MYCAPSSA improved clinical symptoms and other patient-reported outcomes compared to long-acting injectable somatostatin receptor ligands in patients with acromegaly. In addition, MYCAPSSA met the pre-specified non-inferiority margin compared to long-acting iSRLs in maintenance of biochemical response. Overall, 80.4% of the randomized patients maintained or improved their symptoms score during the run-in phase compared to baseline. The company believes the findings validate previous results from the open-label, Phase 3 CH-ACM-01 study of MYCAPSSA in which patients switching to MYCAPSSA from iSRLs reported significant reduction in joint pain, extremity swelling and fatigue.
|Over a month ago|
Chiasma reports Q4 EPS (32c), consensus (35c) » 16:0303/0403/04/21
Reports Q4 revenue…
Reports Q4 revenue $964,000, consensus $1M. The company exited Q4 with $135.4M of cash, cash equivalents and marketable securities. "We continue to gain traction with our phased launch of MYCAPSSA and are encouraged by the positive feedback from physicians and patients," stated Raj Kannan, CEO of Chiasma. "We made significant progress with payors in covering over 150 million lives, and we have implemented a number of innovative initiatives to both educate our customers and support patients who want to switch to MYCAPSSA."
Chiasma price target raised to $12 from $10 at H.C. Wainwright » 06:1303/0203/02/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Douglas Tsao raised the firm's price target on Chiasma to $12 from $10 and reiterates a Buy rating on the shares following the addition of carcinoid syndrome to his model. The analyst believes it is likely that Chiasma will pursue development for Mycapssa for the treatment of carcinoid syndrome.
Chiasma appoints John Doyle as CFO » 07:1701/1901/19/21
Chiasma (CHMA) announced…
Chiasma (CHMA) announced the hiring of John Doyle as its new CFO. As previously reported, Mark Fitzpatrick, Chiasma's current President and Principal Financial Officer, will remain with the company in a consulting role through June 30, 2021 to help facilitate a transition of responsibilities to Mr. Doyle. Prior to joining Chiasma, Mr. Doyle served as VP of Finance and Investor Relations at Verastem (VSTM).
Chiasma price target lowered to $15 from $19 at Piper Sandler » 11:5001/1101/11/21
Piper Sandler analyst…
Piper Sandler analyst Edward Tenthoff lowered the firm's price target on Chiasma to $15 from $19 and keeps an Overweight rating on the shares after the company pre-announced 2020 net Mycapssa sales of $900,000 to $1.1M, slightly below his Q4 estimate of $1.1M. The COVID-19 pandemic is slowing the Mycapssa launch, says the analyst, who trimmed net sales forecast to $20.1M from $26.9M this year. Mycapssa is the first and only oral therapy for acromegaly patients approved by the FDA last June, Tenthoff points out.
|Over a quarter ago|
Chiasma provides update, sees FY21 operating expenses $80M-90M » 16:1001/0601/06/21
Chiasma reviewed its 2020…
Chiasma reviewed its 2020 accomplishments and previewed its anticipated 2021 corporate milestones. MYCAPSSA Approved in the U.S. as the first and only oral somatostatin analog, SSA, for the long-term maintenance treatment of patients with acromegaly who responded to and tolerated treatment with octreotide or lanreotide. Approval was based on the positive CHIASMA OPTIMAL Phase 3 trial results which were published in the Journal of Clinical Endocrinology & Metabolism and presented at the 2020 Endocrine Society Annual Meeting along with six other scientific posters relevant to MYCAPSSA. Commercial Launch of MYCAPSSA in the U.S. Late in the third quarter of 2020, Chiasma commenced the initial phase of the MYCAPSSA U.S. commercial launch with a focused salesforce calling on approximately one-third of key prescribing accounts. Chiasma progressed to the second phase of the launch at the beginning of 2021 with an expanded salesforce hired during the fourth quarter of 2020. Progression to the final phase of the launch with a full-strength salesforce is expected after market conditions improve beyond the COVID era...Anticipated 2021 Milestones and Related Guidance: Grow MYCAPSSA revenues in the U.S. by building on the progress made with the initial, focused selling effort in the first four months since launch: Chiasma plans to drive adoption for MYCAPSSA with a broader group of physicians by expanding from a 36-person customer-facing team today to an approximately 45-person customer-facing team as market challenges associated with COVID-19 recede and payer coverage continues to expand...Operating expense for the full year 2021 is expected to be in a range of $80 million to $90 million, including estimated stock-based compensation expense in a range of $5 million to $6 million. This guidance is based on the company's current U.S. commercial plans and excludes expenditure for potential EU launch preparations of MYCAPSSA and potential additional new product development programs.
Chiasma to host conference call » 10:5511/3011/30/20
Management hosts an…
Management hosts an expert panel on Acromegaly and the MPOWERED Phase 3 Trial results on a conference call to be held on November 30 at 11 am. Webcast Link