Mesoblast, An Aussie Biotech Cooking Up A Turkey For American Investors
Alpha Exposure • 15 Comments
Alpha Exposure • 15 Comments
Fri, Jun. 17, 7:06 AM
- Hill Rom Holdings (NYSE:HRC) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $62 (20% upside) from $54.
- Arbutus Biopharma (NASDAQ:ABUS) upgraded to Neutral from Sell by Chardan. Price target is $3.25 (1% downside risk).
- Achaogen (NASDAQ:AKAO) upgraded to Outperform from Neutral by Wedbush. Price target raised to $10 (111% upside) from $7.
- PRA Health Sciences (NASDAQ:PRAH) upgraded to Overweight from Sector Weight by KeyBanc. Price target is $55 (25% upside).
- Agios Pharmaceuticals (NASDAQ:AGIO) upgraded to Buy from Hold by JPMorgan. Price target raised to $62 (30% upside) from $50.
- Quidel (NASDAQ:QDEL) upgraded to Outperform from Market Perform by Raymond James. Price target is $21.50 (20% upside).
- Aptose Biosciences (NASDAQ:APTO) upgraded to Buy from Neutral by Roth Capital. Price target raised to $8 (186% upside) from $4.
- Endologix (NASDAQ:ELGX) upgraded to Buy from Hold with a $15.50 (23% upside) price target by Canaccord Genuity.
- Endo International (NASDAQ:ENDP) upgraded to Neutral from Underperform by Mizuho Securities. Price target raised to $16 (5% downside risk) from $13.
- United Therapeutics (NASDAQ:UTHR) downgraded to Neutral from Buy by H.C. Wainwright. Price target lowered to $95 (11% downside risk) from $175.
- Infinity Pharmaceuticals (NASDAQ:INFI) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $1 (32% downside risk) from $11.
- LDR Holding (NASDAQ:LDRH) downgraded to Market Perform from Outperform by Cowen & Company.
- Marinus Pharmaceuticals (NASDAQ:MRNS) downgraded to Perform from Outperform by Oppenheimer. $17 price target removed. Also downgraded to Sector Perform from Outperform by RBC Capital.
- Mesoblast (NASDAQ:MESO) downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $5 (21% upside) from $10.
- Revance Therapeutics (NASDAQ:RVNC) downgraded to Hold from Buy by Brean Capital. Price target removed.
- OraSure (NASDAQ:OSUR) downgraded to Market Perform from Outperform by Raymond James. Price target is $8 (15% upside).
Tue, Jun. 14, 8:16 AM
- Thinly traded micro cap Mesoblast Limited (NASDAQ:MESO) is down 36% premarket on light volume in response to its announcement that development partner Teva Pharmaceutical Industries (NYSE:TEVA) has returned the rights to MPC-150-IM for the treatment of chronic heart failure to Mesoblast. Some analysts had speculated that Teva would back out of the collaboration because it was outside of its core business.
- A 600-subject Phase 3 clinical trial assessing MPC-150-IM in heart failure is ongoing, with 40% of the enrollment target achieved.
- MPC-150-IM is an "off the shelf" cell therapy based on mesenchymal lineage adult stem cells.
- Update: On July 1, the company updated investors on the heart failure study saying top-line data on the primary endpoint is expected in Q1 2017. The anticipated costs to this interim analysis will be ~$13M, well below its existing cash balance of $80M. Its quick assets will be adequate to fund operations for 12-15 months and allow for the inclusion of programs in degenerative disc disease, graft-versus-host disease and biologic-refractory rheumatoid arthritis. A fully discretionary equity facility of up to $90M ($A120M) over 36 months has been established to provide additional liquidity if needed.
Fri, Jun. 3, 11:00 AM
- The trading halt in Mesoblast (NASDAQ:MESO) ADSs, instituted June 1, will remain in effect until June 10, at the company's request. Based on experience, this type of scenario almost always portends negative news.
- Analysts speculate that Teva Pharmaceutical Industries (TEVA -2.3%) could pull out of its collaboration with the company since it lies outside of its core business or the news could relate to an accounting issue, FDA warning or safety matter. In a tweet, TheStreet's Adam Feuerstein speculated that the news could be related to a criminal probe of Osiris Therapeutics (OSIR -1.9%), whose culture-expanded mesenchymal stem cell business Mesoblast acquired in 2013.
- Investors began heading for the exits more than two months before June 1. Shares had slumped 35% from the high of $10.89 on March 17 when halted.
Mon, May 9, 11:52 PM
Fri, Apr. 1, 8:30 AM
- Results from a 17-subject Phase 2a clinical trial assessing Mesoblast Limited's (NASDAQ:MESO) mesenchymal precursor cell (MPC) cell product candidate, MPC-75-IA, in patients with osteoarthritis of the knee showed improvements in pain, function, cartilage thickness and joint structure over 24 months. The data were presented yesterday at the 2016 Osteoarthritis Research Society International World Congress in Amsterdam, The Netherlands.
- The double-blind, placebo-controlled study randomized (2:1) patients aged 18-40 years old who had undergone ACL knee reconstruction surgery 4-6 weeks earlier to receive either a single intra-articular injection of 75M allogeneic MPCs plus hyaluronic acid (HA) or HA alone. Pain, function and quality of life metrics were assessed over 24 months. Joint space width indicating cartilage thickness was measured by X-ray and structural changes in the knee by magnetic resonance imaging (MRI).
- The study met its primary safety and secondary efficacy endpoints. No cell therapy-related adverse events were reported.
- The MPC + HA group showed greater improvement in a composite measure of knee injury and osteoarthritis called KOOS score compared to HA alone. The MPC + HA was also superior to HA alone in bodily pain score. All results were statistically significant at all time points. By X-ray, the MPC + HA group showed greater joint space and MRI analysis showed less tibial bone expansion. There was also a trend towards less medial tibial volume loss over 26 weeks in the MPC + HA cohort.
- The results were consistent with the protective and pro-regenerative effects of the company's allogeneic MPCs on joint cartilage observed in preclinical models. According to Mesoblast, the data support further study of the effects of allogeneic MPCs on cartilage preservation and longer-term osteoarthritis outcomes in patients at high risk of disease progression or with established disease.
- There are ~200K ACL reconstruction procedures performed in the U.S. each year. As many as 80% of post-ACL knees progress to osteoarthritis after 5-15 years. About 1M meniscal reconstruction procedures are done each year as well with similar rates of progression to knee osteoarthritis.
- MESO shares are up a fraction premarket.
- Now read Mesoblast, An Aussie Biotech Cooking Up A Turkey for American Investors
Wed, Mar. 2, 8:39 AM
- Thinly traded micro cap Mesoblast Limited (NASDAQ:MESO) is up 15% premarket on light volume. Shares have rallied over 80% since mid-February when the company reported encouraging results from its stem cell candidate, remestemcel-L (MSC-100-IV) in children with steroid-refractory acute graft versus host disease.
- Previously: Mesoblast's cell therapy shows encouraging results in children with aGvHD disease; shares up 22% (Feb. 22)
Fri, Feb. 26, 1:53 PM
- GlaxoSmithKline (GSK -0.9%) initiated with Hold rating and 1400p price target (-0.7% downside risk) by Cantor Fitzgerald.
- Shire plc (SHPG -0.6%) initiated with Buy rating by Cantor Fitzgerald.
- Insulet (PODD +8.7%) initiated with Sell rating and $15 (53% downside risk) price target by Empire Asset Management.
- MacroGenics (MGNX +2.2%) initiated with Equal Weight rating and $20 (29% upside) price target by Morgan Stanley.
- Biogen (BIIB +0.8%) initiated with Buy rating and $345 (30% upside) price target by Citigroup.
- Boston Scientific (BSX -0.3%) initiated with Buy rating and $21 (22% upside) price target by SunTrust Robinson Humphrey.
- Other initiations by Citigroup: Amgen (AMGN +1.1%) Neutral rating and $165 (11% upside) price target; Celgene (CELG +1.4%) Buy rating and $130 (25% upside) price target; Regeneron Pharmaceuticals (REGN) Buy rating and $480 (22% upside) price target; Alexion Pharmaceuticals (ALXN +0.1%) Neutral rating and $165 (18% upside) price target.
- IMS Health Holdings (IMS +0.2%) initiated with Outperform rating and $31 (19% upside) price target by Leerink Swann.
- Ocera Therapeutics (OCRX +5.7%) initiated with Buy rating and $10 (229% upside) price target by Brean Capital.
- Repligen (RGEN +3.8%) initiated with Buy rating and $36 (35% upside) price target by Craig-Hallum.
- Mesoblast (MESO -2.2%) initiated with Neutral rating and $5.50 (12% downside risk) price target by Chardan Capital.
- Ultragenyx Pharmaceutical (RARE +1.2%) initiated with Buy rating and $80 (29% upside) price target by Leerink Swann.
- Teva Pharmaceutical Industries (TEVA -0.2%) initiated with Outperform rating with $68-71 (21% upside from midpoint) price target by Wells Fargo.
- Medivation (MDVN +9.8%) initiated with Buy rating and $46 (28% upside) price target by Bank of America.
- Collegium Pharmaceutical (COLL -0.1%) initiated with Outperform rating and $35 (83% upside) price target by William Blair.
Mon, Feb. 22, 11:35 AM
- Thinly traded micro cap Mesoblast Limited (MESO +22%) heads north on increased volume in response to its announcement of positive results from a study of its mesenchymal stem cell product candidate, remestemcel-L (MSC-100-IV) in 241 children with steroid-refractory acute graft versus host disease (aGvHD) after a bone marrow transplant. The data were presented at the BMT Tandem Meetings in Honolulu, Hawaii.
- Children treated with remestemcel-L showed an overall response rate of 65% at Day 28. The response rate jumped to 81% when remestemcel-L was used as front-line therapy following steroid failure.
- In patients with gastrointestinal and liver disease (highest mortality risk) the overall response rates were 65% and 62%, respectively.
- Non-responders at Day 28 who underwent extended therapy with remestemcel-L experienced significantly improved survival (72% versus 18%; p=0.003).
- The company is currently conducting a 60-subject Phase 3 study assessing the safety of remestemcel-L as front-line therapy in children with steroid-refractory aGvHD that will support a Biologics License Application (BLA) in the U.S. According to clinicaltrials.gov, the estimated study completion date is January 2017.
Tue, Feb. 16, 4:46 PM
Tue, Feb. 16, 10:27 AM
- Thinly traded micro cap Mesoblast Limited (MESO +8.9%) heads north on light volume in response to its announcement of positive interim results from a Phase 2 clinical trial assessing its cell therapy for the treatment of patients with rheumatoid arthritis (RA), including those who have failed treatment with one or more biologic agents.
- Data from the first cohort of 24 subjects showed that a single intravenous infusion of the lower dose (1M MPCs/kg) of MPC-300-IV, the company's proprietary Mesenchymal Precursor Cell (MPC) product candidate, was safe and produced early and sustained clinical responses. 47% (n=11) of all MPC-treated patients and 60% (n=14) of those who failed to respond to 1-2 biologics achieved ACR20 compared to 25% and 17%, respectively, for placebo. 71% of the ACR20 achievers responded quickly, as early as one week. 27% (n=6) of MPC-treated patients achieved ACR50 or ACR70 at Week 12 compared to none for placebo. Remission at Week 12 was seen in 20% (n=5) of MPC-treated subjects versus none for placebo.
- Recruitment is underway in a second cohort of 24 patients in whom higher dose (2M MPCs/kg) MPC-300-IV is being assessed. Final results for both cohorts should be available in Q3.
- The primary efficacy endpoints are ACR20, ACR50 and ACR70 response rates at Week 12. The ACR (American College of Rheumatology) metric means the percent improvement in RA symptoms. ACR20, for example, means a 20% improvement in symptoms.
Fri, Jan. 22, 8:23 AM
- Credit Suisse analysts have been very busy lately with a long list of initiations: Acceleron Pharma (NASDAQ:XLRN) Outperform with $50 (47% upside) price target; BioMarin Pharmaceutical (NASDAQ:BMRN) Outperform with $110 (36% upside) price target; Amgen (NASDAQ:AMGN) Outperform with $205 (34% upside) price target.
- Celgene (NASDAQ:CELG) Outperform with $149 (41% upside) price target; Coherus Biosciences (NASDAQ:CHRS) Outperform with $25 (79% upside) price target; Gilead Sciences (NASDAQ:GILD) Outperform with $125 (40% upside) price target.
- Regeneron Pharmaceuticals (NASDAQ:REGN) Neutral with $552 (19% upside) price target; Vertex Pharmaceuticals (NASDAQ:VRTX) Outperform with $151 (59% upside) price target; Alnylam Pharmaceuticals (NASDAQ:ALNY) Outperform with $154 (117% upside) price target.
- Alexion Pharmaceuticals (NASDAQ:ALXN) Neutral rating with $201 (29% upside) price target; Biogen (NASDAQ:BIIB) Neutral with $322 (23% upside) price target; XenoPort (NASDAQ:XNPT) Underperform with $4 (16% downside risk) price target.
- PTC Therapeutics (NASDAQ:PTCT) Outperform with $36 (33% upside) price target; Mesoblast Limited (NASDAQ:MESO) Outperform with $10 (92% upside) price target and Incyte (NASDAQ:INCY) Outperform with $110 (49% upside) price target.
Tue, Jan. 12, 1:00 PM
- Based on discussions between development partner Teva Pharmaceutical Industries (TEVA +1.2%) and the FDA, the size of a Phase 3 clinical trial assessing Mesoblast Limited's (MESO -0.8%) cell therapy candidate, MPC-150-IM, in patients with chronic heart failure (CHF) will be cut from 1,165 to ~600. The reduction was enabled by a change in the primary endpoint brought about by positive follow-up data in a Phase 2 study that showed the successful prevention of recurrent heart failure-related major adverse cardiovascular events (HF-MACE) for three years from a single injection of MPC-150-IM.
- In the Phase 2, no MPC-150-IM-treated patients experienced HF-MACE over 36 months compared to 11 in the control group (p<0.001), In patients with advanced heart failure, 71% of the control arm experienced at least one HF-MACE versus zero for the MPC-150-IM cohort (p<0.001).
- The revised endpoint will be a comparison of recurrent HF-MACE in patients treated with MPC-150-IM and control.
- The size reduction will significantly shorten the time to completion. A second confirmatory study will be run in parallel using the same endpoint also in ~600 subjects.
- MPC-150-IM is an "off the shelf" cell therapy based on mesenchymal lineage adult stem cells.
Dec. 17, 2015, 6:08 AM
- Mesoblast (MESO +9.8%) FQ1 results: Revenues: $7.5M (+7.1%); R&D Expense: $11.1M (-14.0%); SG&A: $5.5M (-20.3%); Net Loss: ($13.2M) (+14.8%); Loss Per Share: ($0.39) (+20.4%); Quick Assets: $77.8M (-29.7%).
- No guidance given.
Dec. 16, 2015, 5:02 PM
- Mesoblast (NASDAQ:MESO): FQ1 EPS of -$0.39
- Revenue of $7.51M (+7.7% Y/Y)
Nov. 27, 2015, 7:25 AM
- Regenerative medicine firm Mesoblast (NASDAQ:MESO) announces that Japan's National Health Service has established reimbursement for its TEMCELL (MSC-100-IV) mesenchymal stem cell product for the treatment of acute graft versus host disease (aGVHD) after an allogeneic bone marrow transplant (BMT). Market launch will commence in February by licensee JCR Pharmaceuticals.
- The approved dosing regimen is eight doses of 2M cells/kg delivered as an IV infusion. For patients with persistent symptoms beyond four weeks, an additional 2M cells/kg may be administered each week for four more weeks.
- The reimbursement is 868,680 yen or $7,079 per bag of 72M cells. The average adult is expected to receive 16 to 24 bags so the total reimbursement will be about 13.9M to 20.8M yen or $113,000 to $170,000.
- According to the CDC, there are ~30K allogeneic BMTs performed each year worldwide, 8,900 in the U.S. Half will develop aGVHD.
- The company expects to complete enrollment in its U.S.-based 60-subject Phase 3 study assessing MSC-100-IV (remestemcel-L) in pediatric patients this quarter. Top-line results should be available in Q3 2016. If successful, a Biologics License Application (BLA) will be filed by the end of 2016.
Nov. 2, 2015, 3:46 PM
- Melbourne, Australia-based Mesoblast (OTCPK:MEOBF)(OTCPK:MBLTY) is set for its U.S. IPO of 5,742,510 American Depositary Shares at ~$12 per ADS. Each ADS represents five ordinary shares and will trade on the Nasdaq Global Select Market under the symbol "MESO."
- The regenerative medicine firm develops products based on mesenchymal lineage adult stem cells (MLCs). According to the company, it has the most advanced regenerative medicine portfolio in world, with five MLC product candidates in Stage 3 development (ongoing or planned). Its lead programs include MPC-150-IM for chronic heart failure (partnered with (TEVA +2.9%)); MPC-06-ID for chronic low back pain caused by disc degeneration; and TEMCELL/MSC-100-IV for acute graft versus host disease.
- F2015 Financials ($M): Revenues: 19.8 (-15.5%); Operating Expenses: 131.4 (+20.5%); Net Loss: (96.2) (-27.4%); CF Ops: (101.0) (-34.9%).
Mesoblast Ltd. engages in the development of bio-therapeutics based on its proprietary cell-based and protein technologies. Its proprietary cell-based core technologies include highly purified, immunoselected Mesenchymal Precursor Cells (MPCs), culture-expanded Mesenchymal Stem Cells (MSCs),... More
Other News & PR