On Wednesday, H.C. Wainwright raised the price target on Acelyrin Inc (NASDAQ: SLRN) shares to $8.00 from the previous $6.00, maintaining a Neutral rating on the stock. The adjustment follows Acelyrin's recent announcement of its third-quarter earnings for 2024 and the provision of corporate updates during a conference call.
Acelyrin completed a critical end of Phase 2 meeting with the FDA, securing agreement on the design of the upcoming Phase 3 trial for its drug candidate lonigutamab (loni). This includes consensus on the trial's size, endpoints, and dosing schedule.
The biopharmaceutical company is preparing to share new Phase 1/2 data and details about the Phase 3 program at an investor event projected for the first quarter of 2025. The initiation of the Phase 3 trial is also anticipated within the same timeframe.
During the development of lonigutamab, Acelyrin conducted multiple cohorts to determine the optimal dosing regimen. Cohort 1 tested a 40 mg dosage administered every three weeks, while Cohort 2 experimented with a loading dose of 50 mg followed by 25 mg weekly. Cohort 3 explored a 50 mg dose every four weeks.
Currently, Cohort 4 is underway, assessing a range of 70-100 mg every four weeks, with the inclusion of a 100 mg dose to potentially accelerate the time to response. This cohort is also employing MRI to measure the response of proptosis, a condition associated with bulging eyes.
The company has yet to decide on the specific dose for the Phase 3 trial but aims to refine the dosing to balance efficacy with safety, particularly to mitigate hearing impairment observed with a similar drug, teprotumumab, developed by Amgen (NASDAQ:AMGN), which is not rated.
Acelyrin plans to present data from the initial three cohorts at the upcoming investor event, with preliminary findings from Cohort 4, although it may not be conclusive. Cohort 3 included 8 patients, and Cohort 4 is expected to enroll approximately 8 patients, suggesting that data from an additional 10-16 patients will be available for discussion at the event.
In other recent news, Acelyrin Inc. has disclosed financial details of its ValenzaBio acquisition, providing investors with a comprehensive view of the fiscal implications of the merger.
The company has also reported positive data from a Phase 1/2 study of its drug lonigutamab for Thyroid Eye Disease (TED). As part of a strategic pivot, Acelyrin has halted the development of izokibep, reduced its workforce by 33%, and discontinued the anti-c-KIT program, SLRN-517, to focus on lonigutamab.
Morgan Stanley (NYSE:MS) has adjusted its stock price target for Acelyrin from $13.00 to $6.00, maintaining an Equalweight rating. Meanwhile, Piper Sandler has maintained its Overweight rating on Acelyrin shares, anticipating further Phase 1/2 data on lonigutamab.
These recent developments highlight Acelyrin's strategic moves to strengthen its drug portfolio and financial position in the market. The company's cash position as of June 30, 2024, was reported at $635 million, expected to last until mid-2027. These updates provide investors with crucial information about Acelyrin's financial health and strategic trajectory.
InvestingPro Insights
Recent InvestingPro data provides additional context to Acelyrin Inc's (NASDAQ: SLRN) financial position and market performance. The company's market capitalization stands at $596.85 million, reflecting its current valuation in the biotech sector. Despite the recent price target increase by H.C. Wainwright, Acelyrin's stock is trading at 65% of its 52-week high, with a price of $5.98 as of the previous close.
InvestingPro Tips highlight both challenges and potential opportunities for Acelyrin. The company is quickly burning through cash, which is not uncommon for biotech firms in the development stage. This aligns with the article's focus on Acelyrin's ongoing clinical trials and preparation for Phase 3 studies. Additionally, Acelyrin is not profitable over the last twelve months, with a negative operating income of $423.82 million for the same period.
On a positive note, Acelyrin holds more cash than debt on its balance sheet, providing some financial flexibility as it advances its drug candidates. The stock has also shown strong performance over the last three months, with a 47.29% price total return, possibly reflecting investor optimism about the company's progress with lonigutamab.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for Acelyrin, which could provide valuable insights into the company's financial health and market position as it moves forward with its clinical development programs.
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